Be a Smart Investor: June 2020

Tuesday, June 30, 2020

AKRO Soars After-hrs, ATHE On Watch, INO Reports COVID-19 Vaccine Trial Data, ZYNE Down But Not Out

Today's Daily Dose brings you news about promising histological data from Akero's phase II NASH study; positive results of Inovio's phase I clinical trial of COVID-19 vaccine candidate INO-4800; Zynerba's Fragile X Syndrome trial results; Chiasma's stock offering; update on Alterity's phase I Multiple System Atrophy trial and disappointing results of Oncocyte's DetermaDx liquid biopsy test.

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ConocoPhillips To Continue To Suspend Forward-looking Guidance - Quick Facts

ConocoPhillips (COP) said Tuesday it will continue to suspend forward-looking guidance and sensitivities due to the ongoing variability and uncertainty in the outlook for production curtailments.

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FDA OKs Merck's Keytruda As First-line Treatment For Metastatic Colorectal Cancer

Pharma major Merck & Co. said the U.S. Food and Drug Administration (FDA) approved its cancer drug Keytruda (pembrolizumab) for intravenous injection as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

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Coronavirus Concerns May Lead To Pullback On Wall Street

The major U.S. index futures are currently pointing to a lower open on Tuesday, with stocks likely to give back ground following the strong upward move seen in the previous session.

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Conagra Brands Guides Q1 Adjusted Earnings In Line With Estimates - Quick Facts

While reporting financial results for the fourth quarter on Tuesday, Conagra Brands, Inc. (CAG) provided only its adjusted earnings and organic net sales growth guidance for the first quarter of fiscal 2021.

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Saniderm Advanced Hand Sanitizer Recalled After FDA Warning

UVT, Inc. recalled 38,830 liters of Saniderm Advanced Hand Sanitizer following a warning by the U.S. Food and Drug Administration about the potential presence of undeclared Methanol, a toxic chemical. The FDA last week urged consumers not to use any hand sanitizer products made by Mexico-based Eskbiochem SA de CV.

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FDA Snubs HRTX Again, ICPT Disappoints, KNSA Hits Right Notes, Is The Writing On The Wall For VRCA?

Today's Daily Dose brings you news about Akero's near-term catalyst; FDA denying approval to Heron's HTX-011 for the management of postoperative pain and Intercept's OCA for treatment of NASH; Kiniksa's RHAPSODY trial results, PDS Biotechnology's KOL meeting and regulatory update on Verrica's VP-102.

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Stock Alert: Kiniksa Shares Up 31% In Premarket On Positive Data From Phase 3 Trial Of Rilonacept

Shares of Kiniksa Pharmaceuticals Ltd. (KNSA) are soaring over 31% in pre-market today, after the company reported positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling, in recurrent pericarditis.

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Stock Alert: Altimmune Shares Up 20% In Premarket On $4.7 Mln Award From US DoD

Shares of Altimmune Inc. (ALT) are surging over 20% in pre-market today, after the company announced that it has been awarded $4.7 million from the U.S. Army Medical Research & Development Command or USAMRDC to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19.

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Gilead Prices Remdesivir At $390 Per Vial; 5-day Treatment To Cost $2,340 Per Patient

Gilead Sciences (GILD) has decided to price remdesivir at $390 per vial for governments of developed countries. The company said this price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. In the U.S. also, the same government price of $390 per vial will apply. Based on current treatment patterns, the vast majority of patients are anticipated to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient. For U.S. private insurance companies, the price will be $520 per vial.

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DoD Awards $4.7 Mln To Altimmune To Fund Phase 1/2 Clinical Trial Of T-COVID - Quick Facts

Biopharmaceutical company Altimmune, Inc. (ALT) announced Monday that it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19.

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Incyte Receives Approval For Tabrecta In Japan For Patients With Advanced NSCLC With METex14

Biopharmaceutical company Incyte Corp. (INCY) announced Monday that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC).

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Boston Scientific Gets FDA 510(k) Clearance For LUX-Dx Insertable Cardiac Monitor System

Boston Scientific Corp. (BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-DxInsertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

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This Day That Year: Adaptive Biotechnologies (ADPT)

Shares of Adaptive Biotechnologies Corp. (ADPT) have gained over 200 percent from their 52-week low of $15.19, recorded in March of this year, and trade around $46.

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Stock Alert: IBio Shares Surge 66% In Pre-Market

Shares of iBio Inc. (IBIO) are soaring over 66% in pre-market today, after the company announced that it would be added to the Russell 2000 and Russell 3000 indexes as part of this year's reconstitution. The additions would be made effective after the U.S. markets open on June 29, 2020.

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Stock Alert: MDC Partners Stock Spikes 137% In Premarket On Proposed Combination With Stagwell

Shares of MDC Partners Inc. (MDCA) are rallying over 137% in pre-market today, after Stagwell Media LP announced a proposed combination with MDC Partners.

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Stock Alert: Zogenix Shares Up 17% In Early Trade On FDA Approval For Fintepla

Shares of Zogenix Inc. (ZGNX) are rising over 17% in pre-market today, after the pharmaceutical company announced that the U.S. FDA has approved FINTEPLA oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

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Stock Alert: Applied DNA Sciences Set To Join Russell Microcap Index; Stock Up 8% In Premarket

Shares of Applied DNA Sciences Inc. (APDN) are currently trading at $9.98, up 70 cents or 7.54% in the pre-market session today. The stock has been trading in the range of $2.52 - $23.20 for the past one year, and closed Thursday's trade at $9.28, up $1.66 or 21.78%.

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Stock Alert: Big Lots Stock Up 10% In Premarket On Positive Business Trends

Shares of Big Lots Inc. (BIG) are rising over 10% in premarket today, after the retail giant said it has seen a "continuation of the strong demand that began in mid-April, with quarter-to-date comparable sales through fiscal June increasing well ahead of outlook."

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Vaxart (VXRT) Gains 400% In 4 Months

Shares of Vaxart Inc. (VXRT) closed at a two-year high of $6.26 on Thursday, thanks to the Company's pipeline progress, especially the COVID-19 vaccine program.

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Biotech Stocks Facing FDA Decision In July 2020

The first half of 2020 looks set to end on an encouraging note for new drug approvals despite the ongoing coronavirus pandemic. Let's take a look at the biotech stocks facing FDA decision in July.

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Stock Alert: Accenture Touches New 52-week High After Q3 Results

Shares of Accenture plc (ACN) are rising than 7 percent or $15.16 in Thursday's morning trade at $217.00, after touching a new 52-week high of $217.86 earlier as the consulting, technology and outsourcing services provider's first-quarter financial results beat analysts' estimates.

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TTDeye Brand Colored Contact Lenses Recalled

Chengdu Ai Qin E-commerce Co., Ltd has recalled 1362 pairs of TTDeye Brand colored contact lenses, which were found to be distributed without FDA clearance and may pose a threat to health, the U.S. Food and Drug Administration said in a statement.

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Renewed Coronavirus Concerns May Lead To Continued Weakness On Wall Street

The major U.S. index futures are currently pointing to a lower opening on Thursday, with stocks likely to see further downside following the sell-off seen in the previous session.

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Stock Alert: Safe-T Group Shares Up 21% In Premarket On PAOF Launch

Shares of Safe-T Group Ltd. (SFET) are rising over 21% in pre-market today, after the company announced the launch of its Perimeter Access Orchestration Fabric or PAOF designed to take its Zero Trust Network Access or ZTNA solution to the next level.

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Rite Aid Withdraws FY21 Outlook Amid COVID-19 - Quick Facts

While reporting financial results for the first quarter of fiscal 2021 on Thursday, drugstore chain Rite Aid Corp. (RAD) said it is withdrawing the financial guidance for the full-year 2021, which was initiated on March 16, 2020.

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Darden Restaurants Guides Q1 Results Above View - Quick Facts

While reporting financial results for the third quarter on Thursday, Darden Restaurants, Inc., (DRI) said it is providing a financial outlook for the first quarter instead of its usual practice of providing an annual outlook, due to uncertainty surrounding future business performance stemming from COVID-19.

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Accenture Narrows FY20 Outlook Range; Boosts Dividend 10% - Quick Facts

While reporting financial results for the third quarter on Thursday, Accenture Plc (ACN) narrowed its earnings and revenue growth guidance for the full-year 2020 and provided revenue guidance for the fourth quarter.

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ALDI Recalls Garden Salad For Potential Cyclospora Infection

Grocery retailer ALDI has recalled Little Salad Bar Garden Salad citing possibility for Cyclospora infection, the U.S. Food and Drug Administration said in a statement. The recall follows an investigation by the U. S. health officials, including the FDA, Centers for Disease Control and Prevention as well as state and local partners, about a multistate outbreak of Cyclospora infections.

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Mitie Group FY Pre-tax Profit Rises; To Buy Interserve's Facility Management Business

Mitie Group plc (MTO.L), a provider of facilities management and professional services, on Thursday reported preliminary results for fiscal year 2019/20.

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Healthcare IPOs For June 26

The IPO activity in the U.S. pharma/biotech sector has had a strong showing in the month of June, with 14 listings so far. Now, let's take a look at the biotech IPOs scheduled for Friday, June 26, 2020.

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Chinese Coronavirus Vaccine Candidate Approved For Human Trials In UAE

Health authorities from the United Arab Emirates (UAE) announced the commencement of the world's first phase III clinical trial of a COVID-19 inactivated vaccine, the UAE Embassy in China said in a tweet. The human trial will be conducted in the UAE through a partnership between Chinese pharma company Sinopharm China National Biotec Group and UAE's Group 42.

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Translate Bio (TBIO) Delivers 175% Gain In Little Less Than 3 Months

Shares of Translate Bio Inc. (TBIO) touched an all-time high of $27.24 in intraday trading yesterday (Jun.23, 2020), thanks to the expanded collaboration with Sanofi Pasteur, the vaccines global business unit of Sanofi (SNY), to develop mRNA vaccines across all infectious disease areas.

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Profit Taking, Coronavirus Concerns May Weigh On Wall Street

The major U.S. index futures are pointing to a lower open on Wednesday, with stocks likely to give back ground following the upward move seen over the two previous sessions.

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Patterson Not Issuing FY21 Outlook Amid COVID-19 - Quick Facts

While reporting financial results for the fourth quarter on Wednesday, Patterson Cos., Inc. (PDCO) said it is not issuing earnings guidance for the full-year 2021 at this time, due to the ongoing disruption of North American and international market conditions and the inability to accurately predict the economic effects of COVID-19 and related government action.

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INO Hits New High, APYX Expands Footprint, TBIO/SNY To Begin COVID-19 Vaccine Trial In Q4

Today's Daily Dose brings you news about the expanding footprint of Apyx Medical's Helium Plasma Technology products; Inovio securing a $71 million funding from the U.S. Department of Defense for its COVID-19 vaccine delivery systems and Myovant's positive results from its second phase III trial of Relugolix combination therapy in women with pain associated with endometriosis, among others.

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Stock Alert: Barnwell Shares Spike 94% In Pre-Market On Narrower Q1 Loss

Shares of Barnwell Industries Inc. (BRN) are rallying over 94% in pre-market today, after the company reported a narrower loss for the first quarter, fueled by strong revenue growth.

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AES Corp. To Sell Stake In Indian Coal-fired Power Plants; Backs FY20 Adj. EPS Outlook

AES Corp. (AES) said Tuesday that it has agreed to sell its entire equity interest in the 1,740 MW OPGC 1&2 coal-fired power plants in Odisha, India to Adani Power Limited. Through this sale, AES' generation in MWh from coal will be reduced to 35 percent of total generation, from 45 percent.

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Futures Pointing To Higher Open After Recovering From Overnight Slump

The major U.S. index futures are currently pointing to a significantly higher open on Tuesday after recovering from an overnight nosedive.

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Stock Alert: Inovio Pharma Shares Up 12% In Pre-Market On $71 Mln Contract From DoD

Shares of Inovio Pharmaceuticals Inc. (INO) are rising over 12% in pre-market today, after the company announced that it has received $71 million funding from the U.S. Department of Defense or DoD to support the large-scale manufacture of the company's proprietary CELLECTRA 3PSP smart device and the procurement of CELLECTRA 2000 devices, which are used to deliver INO-4800 directly into the skin.

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AbbVie Says FDA To Review SNDA For IMBRUVICA In Combination With Rituximab - Quick Facts

Biopharmaceutical company AbbVie Co. (ABBV) announced Tuesday that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL).

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Palatin Technologies Developing PL8177 As Treatment For COVID-19 - Quick Facts

Biopharmaceutical company Palatin Technologies, Inc. (PTN) announced Tuesday that it is developing PL8177 as a treatment for patients with COVID-19, and having hypoxemic respiratory failure with or without acute respiratory distress syndrome (ARDS).

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Stock Alert: Apyx Stock Up 43% In Pre-Market On Approval To Sell Helium Products In New Countries

Shares of Apyx Medical Corp. (APYX) are rallying over 43% in pre-market today, after the company announced that it has obtained regulatory approval to market and sell its Helium Plasma Technology products in five new countries: Australia, Brazil, Israel, Taiwan and Thailand. The company has contracted with distributors to market and sell its products in each country.

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Stock Alert: Translate Bio Shares Surge 78% In Premarket On MRNA Vaccines Pact Expansion

Shares of Translate Bio Inc. (TBIO) are soaring over 78% in pre-market today after the company and Sanofi Pasteur, the vaccines global business unit of Sanofi, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.

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North Star Sweet & Salty Caramel Trail Mix Recalled For Undeclared Cashews

Flagstone Foods LLC is recalling certain North Star Sweet & Salty Caramel Trail Mix citing the possible presence of undeclared cashews, an allergen, the U.S. Food and Drug Administration announced in a statement. The recall involves its 14-ounce, plastic stand-up resealable packages, marked with UPC Code 0- 80948-63064-4 and lot code # 05M04210 with an expiration date of 04/22/2021.

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MYOV To Report SPIRIT 1 Data, EVLO Joins COVID-19 Drug Race, NVTA Loosens Purse Strings

Today's Daily Dose brings you news about inclusion of Evelo's EDP1815 in COVID-19 trial; analyst upgrade of Five Prime; Gilead's plan to test inhaled version of experimental antiviral medicine Remdesivir; Hepion's efficacy of NASH drug candidate in mouse models of renal fibrosis; Invitae's acquisition of ArcherDX for about $1.4 billion and expanded approval of Karyopharm's Xpovio.

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This Day That Year: Personalis (PSNL)

Shares of Personalis Inc. (PSNL) are down 61 percent from their 52-week high of $31.88, recorded last June, and trade around $12.

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Hydroxychloroquine Unlikely To Benefit Covid-19 Patients: Study

Anti-malaria drug Hydroxychloroquine may not benefit hospitalized patients with coronavirus (COVID-19), according to clinical trial conducted by the National Institutes of Health (NIH). The NIH stopped the clinical trial after its data and safety monitoring board (DSMB) determined that while there was no harm, Hydroxychloroquine provides no benefit.

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Economic Optimism May Lead To Strength On Wall Street

The major U.S. index futures are currently pointing to a higher opening on Monday, with stocks likely to move back to the upside following the pullback seen in the previous session.

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FDA, CDC Investigate Cyclospora Outbreak Linked To Bagged Salads

The U. S. health officials, including the Food and Drug Administration, Centers for Disease Control and Prevention as well as state and local partners, are investigating a multistate outbreak of Cyclospora infections potentially linked to bagged salad products sold by three retailers.

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Children's Cough Syrups Recalled For Faulty Dosing Cups

GSK Consumer Healthcare, a joint venture between GlaxoSmithKline plc and Pfizer, Inc., is recalling children's Robitussin and Dimetapp over-the-counter cough syrups citing incorrect dosing cups that could result in overdose, the U.S. Food and Drug Administration said. The dosing cups for the Children's Robitussin Honey product are missing the 5 mL and 10 mL graduations...

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UK firms critical to public health protected from foreign takeovers

Legislation protects those needed in future pandemics who may be struggling now

The UK government is introducing legislation to protect businesses that are key to public health from foreign takeovers.

The changes will give the government the power to protect companies that could be critical in helping the country in future health emergencies but which may be financially struggling to weather the current coronavirus pandemic.

Continue reading...

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Data Readouts Due This Month - Do You Have These Pharma Stocks In Your Portfolio?

The second quarter of 2020 is about to end in just over a week's time. The names of some of the pharma/biotech companies whose data readouts are due this quarter are listed below.

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FDA OKs First Therapy To Treat Tumor-induced Osteomalacia

Biopharmaceutical company Ultragenyx Pharmaceutical Inc. said the U.S. Food and Drug Administration (FDA) approved its bone disease drug Crysvita (burosumab) in the form of injection for the treatment of tumor-induced osteomalacia (TIO) in patients aged two and older. Japanese specialty pharmaceutical company Kyowa Kirin Co., Ltd. is in collaboration with Ultragenyx for Crysvita globally.

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Futures Pointing To Initial Strength On Wall Street

The major U.S. index futures are currently pointing to a higher open on Friday, with stocks likely to move to the upside after showing a lack of direction for two straight sessions.

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Stock Alert: Immuron Shares Soar 48% In Premarket

Shares of Immuron Ltd. (IMRN) are rallying over 48% in pre-market today, after the company announced that it has partnered with CSIRO to produce a new oral therapeutic for clinical evaluation by the US Department of Defense.

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FDA Nod For EPZM, RARE, Court Rules In MYL's Favor, Ocuphire To Hop Onto Nasdaq, ALPN Soars

Today's Daily Dose brings you news about Alpine Immune's deal with AbbVie; FDA approval of Epizyme's TAZVERIK and Ultragenyx Pharma's Crysvita for new indications; reverse merger between privately-held Ocuphire Pharma and Rexahn Pharma and Court ruling in Biogen's Tecfidera patent suit.

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Stock Alert: Aethlon Medical Surges After FDA Okays Hemopurifier Testing For COVID-19

Shares of Aethlon Medical, Inc. (AEMD) are gaining more than 95 percent or $1.34 in Thursday's morning trade at $2.75.

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Stock Alert: Orion Group Shares Rise 24% In Premarket

Shares of Orion Group Holdings Inc. (ORN) are rising over 24% in pre-market today, after the company announced contract awards totaling about $17 million.

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Lingering Coronavirus Fears May Weigh On Wall Street

The major U.S. index futures are currently pointing to a lower opening on Thursday, with stocks likely to see initial weakness following the lackluster performance in the previous session.

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Stock Alert: Marin Software Shares Up 67% In Early Trading

Shares of Marin Software Inc. (MRIN) are currently trading at $2.40, up 97 cents or 67.25% in the pre-market session today. The surge cannot be attributed to any news as of now.

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Kroger Expects To Exceed FY20 Guidance For Adj. Earnings, Same-store Sales

While reporting its financial results for the first quarter on Thursday, Kroger Co. (KR) said it is not reaffirming or providing new guidance for fiscal 2020 due to the difficulty in predicting specific outcomes amid the coronavirus pandemic.

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Stock Alert: Rexahn Pharma Shares Soar 53% In Pre-market On Merger Agreement With Ocuphire

Shares of Rexahn Pharmaceuticals Inc. (REXN) are surging over 53% in pre-market today, after the company announced a definitive merger agreement with Ocuphire Pharma Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company, under which Ocuphire would merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction.

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CEMI Plunges, ELOX To Resume CF Trial, HGEN On Watch, IFRX To Continue COVID-19 Trial

Today's Daily Dose brings you news about the revocation of approval for Chembio's antibody test for COVID-19; resumption of Eloxx's cystic fibrosis trial after a brief pause due to the pandemic; encouraging results of Humanigen's Lenzilumab in COVID-19 patients; InflaRx's COVID-19 trial results and PTC Therapeutics repurposing its investigational cancer drug to treat COVID-19.

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Healthcare IPOs For June 19

The U.S. healthcare sector is seeing a flurry of IPO activity in June. So far this month, 10 companies have made their stock market debut. Let's take a look at the IPOs slated for tomorrow.

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After Market Hours: Eloxx Pharmaceuticals, ABM Industries Up; Hertz, Iveric, Adamas Pharm Tank

Eloxx Pharmaceuticals, Inc. (ELOX) - The clinical-stage biopharmaceutical company's shares surged nearly 50% on Wednesday after-hours trade. The company announced that enrollment in its Phase 2 clinical trial for ELX-02 in cystic fibrosis has been resumed in Israel and Europe after being temporarily paused in response to the COVID-19 pandemic.

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Stock Alert: Armata Pharma Shares Soar 23% In Premarket On $15 Mln Award From US DoD

Shares of Armata Pharmaceuticals Inc. (ARMP) are rising over 23% in pre-market today, after the biotechnology company announced that it has received a $15 million award for a three year program from the U.S. DoD through the Medical Technology Enterprise Consortium or MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

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Futures Pointing To Continued Recovery From Last Week's Pullback

The major U.S. index futures are pointing to a higher open on Wednesday, with stocks poised to extend the rally seen over the course of the three previous sessions.

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Boohoo sales surge as it pays £5.25m for Oasis and Warehouse brands

Consumers turn to online retailer’s loungewear and athleisure during lockdown

Boohoo’s sales surged by 45% in the quarter to the end of May as consumers turned to online shopping during the coronavirus lockdown.

The online fashion retailer, which owns brands including Nasty Gal, Pretty Little Thing, Coast and Karen Millen, said customers were opting for loungewear and athleisure as a result of the shift to a more home-centred lifestyle.

Continue reading...

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Aclaris Says FDA Clears IND To Evaluate ATI-450 MK2 Inhibitor - Quick Facts

Clinical-stage biopharmaceutical company Aclaris Therapeutics, Inc. (ACRS) announced Wednesday that the U.S. Food and Drug Administration (FDA) has allowed an investigational new drug (IND) application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.

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CureVac Receives Regulatory Approval For Phase 1 Clinical Trial Of COVID-19 Vaccine Candidate

Clinical-stage biopharmaceutical company CureVac AG announced Wednesday that it has received regulatory approval from German and Belgian authorities to initiate Phase 1 clinical trial of its SARS-CoV-2 (COVID-19) vaccine candidate. The trial will start promptly and will be conducted in Germany and Belgium.

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AMRN Makes Peace With Apotex, IDYA Cuts Deal With GSK, SLRX On Watch, NBIX, TAK Ink $2Bln Pact

Today's Daily Dose brings you news about Amarin's settlement agreement with Apotex; Annovis Bio's progress in its Alzheimer's drug development program; IDEAYA's deal with GlaxoSmithKline; promising results of Lilly's monarchE study in breast cancer; Neurocrine Biosciences and Takeda's $2 billion-plus collaboration; and Salarius' big event for today.

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Stock Alert: Mid-Con Energy Surges After Turning To Profit

Shares of Mid-Con Energy Partners LP (MCEP) are surging more than 136 percent or $3.77 in Tuesday's morning trade at $6.53. The stock has traded in a range of $1.20 to $17.00 in the past 52 weeks.

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FDA Gives Clearance To First Prescription Video Game For Children With ADHD

The FDA has given clearance to Akili Interactive's EndeavorRx, a video game, as a prescription treatment for children with attention-deficit/hyperactivity disorder.

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Report Of Infrastructure Plan, Retail Sales Data Likely To Generate Early Buying Interest

The major U.S. index futures are currently pointing to a sharply higher open on Tuesday, with stocks likely to see further upside following the substantial rebound seen over the course of the previous session.

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Raw Macadamia Nuts Recalled For Salmonella Concerns

NOW Health Group, Inc. is recalling NOW Real Food Raw Macadamia Nuts citing potential to be contaminated with Salmonella, the U.S. Food and Drug Administration said in a statement. The recall involves NOW Real Food Raw Macadamia Nuts, Unsalted, 8 oz. Pouch with product Code 7119, and Lot#3141055. The lot with best buy date of January 2021 was distributed online and in retail stores.

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Pre-Market Alert: ClearSign Shares Soar 144%

Shares of ClearSign Technologies Corp. (CLIR) are currently trading at $1.94, up $1.15 or 144.79% in the pre-market session today. The stock has been trading in the range of $0.35 - $1.50 for the past one year, and closed Monday's trade at $0.79, down 6 cents or 6.76%.

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FDA Nod For JAZZ's Drug, BYSI's PROTECTIVE-2 Trial Meets Goals, EDSA To Begin COVID-19 Drug Trial

Today's Daily Dose brings you news about Momenta Pharma's positive results from myasthenia gravis trial; BeyondSpring's phase III trial results of Plinabulin in chemotherapy-induced neutropenia; Edesa's progress in COVID-19 drug trial; FDA approval of Jazz Pharma's Zepzelca and Celldex Therapeutics' stock offering.

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Stock Alert: Edesa Biotech Shares Surge 160% On Regulatory Approval To Initiate COVID-19 Study

Shares of Edesa Biotech Inc. (EDSA) are rallying over 160% in pre-market today, after the company announced that it has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients.

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FDA OKs ViiV Healthcare's HIV Medication For Infants And Children

Pharmaceutical company ViiV Healthcare Ltd. said the U.S. Food and Drug Administration (FDA) approved its Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for oral suspension to treat human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients at least four weeks old and weighing at least 3 kg or 6.61 pounds in combination with other antiretroviral treatments.

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Renewed Coronavirus Concerns May Continue To Weigh On Wall Street

The major U.S. index futures are currently pointing to a significantly lower opening on Monday, with stocks likely to extend the sharp pullback seen last week.

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Fruit Jelly Cups Recalled For Choking Risks

Rong Shing Trading NY Inc. is recalling certain Xi Zhi Liang Konjac powder Fruit Jelly Cups, citing choking risks to children, the U.S. Food and Drug Administration said in a statement. The recall was initiated as small jelly cups containing konjac powder have been implicated in choking deaths of children earlier.

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Royalty Pharma To Debut On Nasdaq On June 16

Royalty Pharma is an acquirer of revenue-producing intellectual property - principally royalty interests in marketed and late stage biopharmaceutical products.

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Race For COVID-19 Vaccine: Who Are The Key Players?

When will a safe and effective vaccine for COVID-19 be ready? Vaccine makers are racing against time to develop a vaccine to fight the novel coronavirus. There are more than 130 candidate vaccines in development against SARS-COV-2, the pathogen that causes COVID-19, of which 10 have moved into clinical trials.

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Pre-Market Alert: EMagin Shares Soar 100% On $5.5 Mln DoD Award

Shares of eMagin Corp. (EMAN) are rallying over 100% in pre-market today, after the company announced $5.5 million Department of Defense award.

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Bargain Hunting May Contribute To Initial Rebound On Wall Street

The major U.S. index futures are currently pointing to a sharply higher opening on Friday, with stocks likely to regain ground following the sell-off seen in the previous session.

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Pre-Market Alert: Sorrento Shares Up 11% On COVI-TRACK Diagnostic Test Application

Shares of Sorrento Therapeutics Inc. (SRNE) are rising over 11% in pre-market today, after the company announced that an Application for Emergency Use Authorization or EUA is under review at the U.S. FDA for its COVI-TRACKTM in vitro diagnostic test kit for the independent detection of IgG and IgM antibodies in sera of patients exposed to the SARS-CoV-2 virus.

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Concerns About Second Wave Of Coronavirus May Weigh On Wall Street

The major U.S. index futures are currently pointing to a sharply lower opening on Thursday following the mixed performance seen in the previous session.

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Children's Place Not Providing FY20 Guidance Amid COVID-19 - Quick Facts

While reporting financial results for the first quarter on Thursday, children's specialty apparel retailer The Children's Place, Inc. (PLCE) said it is not providing financial guidance for fiscal 2020 as a result of the continued uncertainty regarding the coronavirus (COVID-19) pandemic.

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Regeneron's (REGN) Resplendent Journey From $60 To $600 In 9 Years

Shares of Regeneron Pharmaceuticals Inc. (REGN), which touched an all-time high of $618.71 on June 2, 2020, have given back some of its gains and trade around $606.

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Just Eat beats Uber to snap up Grubhub for £5.8bn

Planned takeover will create world’s largest food delivery service outside China

European food delivery service Just Eat Takeaway has agreed to buy the US-based app Grubhub for $7.3bn (£5.8bn) in a deal that would create the world’s largest food delivery service outside China.

Confirmation of the all-stock takeover deals a blow to Uber, which has its own food delivery business and was reportedly in discussions with Grubhub.

Continue reading...

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Heathcare IPOs For June 12

The IPO activity in the U.S. healthcare sector is back with a bang this month. Five companies have gone public so far this month. (Inludes Lantern Pharma (LTRN), which is set to begin trading on June 11). Now, let's take a look at the IPOs scheduled for Friday.

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Chico's FAS Slips To Loss In Q1; To Re-evaluate Store Closure Plans - Quick Facts

Chico's Fas Inc. (CHS) on Wednesday reported net loss for the first quarter of $178.29 million or $1.55 per share, compared to net income of $2.03 million or $0.02 per share in the year-ago period.

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Fed Announcement Likely To Be In Focus On Wall Street

The major U.S. index futures are pointing to a higher open on Wednesday with the tech-heavy Nasdaq potentially reaching another new record high.

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Guess? Sees Q2 Revenue Decline Similar To Q1; Postpones Dividend Payment - Quick Facts

While reporting its financial results for the first quarter on Wednesday, Guess? Inc. (GES) said it expects that the COVID-19 crisis will continue to have a material impact on its consolidated financial position, consolidated results of operations, and consolidated cash flows in fiscal 2021.

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United Natural Foods Guides FY20 Above Analysts' Estimates - Quick Facts

While reporting financial results for the third quarter on Wednesday, United Natural Foods, Inc. (UNFI) provided new adjusted earnings and net sales guidance for the full year 2020, above analysts' estimates. The company had withdrawn its prior fiscal 2020 full year guidance on May 12, based on the strength of its fiscal 2020 year-to-date financial performance.

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Graham Refrains From Providing FY21 Outlook Amid COVID-19 - Quick Facts

While reporting financial results for the fourth quarter on Wednesday, Graham Corp. (GHM) said it is not providing financial guidance for fiscal 2021 at this time, due to the significant economic impact of the COVID-19 pandemic on the energy and petrochemical/chemical markets and the lack of visibility as to the duration or the ultimate impact of the pandemic.

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Pfizer Reports Positive Top-line Results From Phase 3 JADE TEEN Trial Of Abrocitinib - Quick Facts

Pfizer Inc. (PFE) announced Wednesday positive top-line results from the Phase 3 JADE TEEN trial of Abrocitinib in adolescents with moderate-to-severe atopic dermatitis (AD). Both doses of abrocitinib met the co-primary endpoints and were generally well tolerated.

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DNLI Halts DNL747 Development, IMRN Skyrockets, XENT's Sinus Implant Gets New C-Code

Today's Daily Dose brings you news about Denali halting the development of DNL747 in Alzheimer's disease and amyotrophic lateral sclerosis; the update on Immuron's research collaboration with the U.S. Naval Medical Research Center that was inked last October; the retirement plan of Inogen CEO and Intersect ENT's Sinus implant getting approval for reimbursement with a new C-Code.

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Dwindling Prader-Willi Syndrome Drug Development Landscape And Hopeful Therapies

Although there are FDA approved therapies for the treatment of growth failure in children with PWS, say, Pfizer's (PFE) recombinant human growth hormone Genotropin (somatropin) and Sandoz/Novartis' Omnitrope, a biosimilar for Genotropin, there is no approved therapy yet to treat hyperphagia or excessive eating, the cardinal symptom of PWS.

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Stock Alert: NanoViricides Signs MoU For Human Coronavirus Drug Development License; Stock Up 10%

Shares of NanoViricides Inc. (NNVC) are rising over 10% in pre-market today, after the company announced that it has signed a Memorandum of Understanding or MoU with respect to anti-viral treatments for coronavirus derived human infections with TheraCour Pharma Inc.

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Stock Alert: Lovesac Shares Up 13% In Premarket On Improved Q1 Results

Shares of The Lovesac Co. (LOVE) are rising over 13% in pre-market today, after the company reported a narrower-than-estimated loss and upbeat revenue for the first quarter.

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Profit Taking May Lead To Pullback On Wall Street

The major U.S. index futures are currently pointing to a significantly lower open on Tuesday, with stocks likely to give back some ground following recent strength.

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Genesco Not Providing Guidance At This Time Amid COVID-19 - Quick Facts

While reporting financial results for the first quarter of fiscal 2021 on Tuesday, specialty retailer Genesco Inc. (GCO) said it is not providing guidance at this time, due to the continued uncertainty in the overall economy amid the COVID-19 outbreak.

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Movado Group Again Refrains From Providing FY21 Guidance - Quick Facts

While reporting financial results for the first quarter of fiscal 202 on Tuesday, Movado Group, Inc. (MOV) said it is again refraining from providing fiscal 2021 guidance, due to the dynamic nature of the COVID-19 crisis and lack of visibility.

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SLNO Fails To Whet Investors' Appetite, OPNT And EBS Slump On Court Ruling, ENOB On Track

Today's Daily Dose brings you news about disappointing results from Soleno's Prader-Willi syndrome trial; the Court ruling in a patent infringement lawsuit filed by Opiant/Emergent against Teva; encouraging additional data from Sarepata's limb-girdle muscular dystrophy Type 2E trial; and Enochian's path forward for ENOB-HV-01, a potential cure for HIV.

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Anti-buyout law would hit UK recovery, say business groups

Plan for tough rules on foreign takeovers comes as UK clashes with China on Hong Kong

Business groups have warned that introducing a law to prevent foreign takeovers that threaten national security could have a “chilling” effect on investment in the UK.

The government is said to be considering new rules that would mean directors could be jailed or companies could be fined hundreds of thousands of pounds for failing to report attempted takeovers by foreign firms that could put national security at risk.

Continue reading...

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Futures Pointing To Continued Strength On Wall Street

The major U.S. index futures are currently pointing to a higher opening on Monday, with stocks likely to extend their recent upward move.

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Eli Lilly, Junshi Biosciences To Conduct Phase 1 Study In China And US For SARS-CoV-2 Antibody

Eli Lilly and Co. (LLY) announced Monday that its Shanghai-based partner Junshi Biosciences has dosed the first healthy volunteer in a study of a potential neutralizing antibody treatment designed to fight COVID-19.

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The Week That Was In COVID: Russia Approves 1st COVID-19 Drug, INO Sues Vaccine Supplier...

The week that just passed by saw the White House selecting vaccine candidates to Operation Warp Speed; new entrants in the COVID-19 drug development space; AstraZeneca's multi deals to produce and supply its vaccine and INOVIO's trials and tribulations, among others.

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Unbelievably Strong Jobs Data Likely To Spark Rally On Wall Street

The major U.S. index futures are currently pointing to a sharply higher opening on Friday following the release of much better than expected jobs data.

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FDA OKs Merck's Recarbrio For Hospital And Ventilator Associated Bacterial Pneumonia

The U.S. Food and Drug Administration approved Merck & Co. Inc.'s combination antibiotic Recarbrio for the expanded indication in the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The drug had received initial approval in the U.S. in July 2019 to treat patients with complicated urinary tract infections and complicated intra-abdominal infecti

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Spanish Puig snaps up Charlotte Tilbury makeup empire

Barcelona-based firm is thought to have fought off bids from Unilever, L’Oréal and Shiseido

The celebrity makeup artist Charlotte Tilbury has handed a control of her namesake makeup and skincare empire to a Spanish fashion and fragrances business in a deal that could have valued the company at up to £1bn just seven years after she started it.

Tilbury, 47, personally owned between half and 75% of the company until signing a deal with the Barcelona-based Puig will likely have handed her a cash payout worth tens of millions of pounds. The Spanish firm also owns brands including Paco Rabanne, Jean Paul Gaultier and Nina Ricci.

Continue reading...

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Stock Alert: Navistar International Up 3% As Q2 Loss Narrower Than Estimates

Shares of Navistar International Corp. (NAV) are advancing more than 3 percent or $0.82 in Thursday's morning trade at $25.66 after the truck maker reported a loss for the second quarter that was narrower than analysts' expectations, while revenues beat expectations.

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Futures Pointing To Initial Weakness On Wall Street

The major U.S. index futures are currently pointing to a lower opening on Thursday, although the futures have fluctuated over the course of the morning.

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INOVIO To Begin Clinical Trials Of COVID-19 Vaccine Candidate In Korea

INOVIO (INO), the International Vaccine Institute, and Seoul National University Hospital have partnered to start a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate INO-4800 in South Korea. This is the first COVID-19 vaccine clinical study approved in South Korea. It will be funded by the Coalition for Epidemic Preparedness Innovations through INOVIO, and supported by the Korea Center for Disease Control and Prevention/Korea National Institute of Health.

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What's On The Healthcare IPO Calendar Friday?

The IPO activity in the U.S. healthcare sector, which has been somewhat tepid in the last two months, is picking up pace . Let's take a look at the U.S. healthcare IPOs scheduled for tomorrow.

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List Of 'Operation Warp Speed' Finalists, SAVA To Reassess AD Study Results; KZR Jumps On MISSION

Today's Daily Dose brings you news about the finalists in 'Operation Warp Speed' COVID-19 vaccine program; FDA approval of Fitbit Flow ventilator for emergency use; an update on Cassava's phase IIb study of PTI-125 in patients with Alzheimer's disease and promising initial data from Kezar Life's MISSION trial.

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Stocks Making Big Moves After Hours: Kezar Life Sciences, Smartsheet, Cloudera, Zuora

Kezar Life Sciences, Inc. (KZR) - Shares of the clinical-stage biotechnology company soared nearly 80% after closing bell. The company's lead drug candidate is KZR-616, a selective inhibitor of immunoproteasome that plays a crucial role in the immune system.

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Stock Alert: Microchip Technology Rises 10% On Better Outlook

Shares of Microchip Technology Inc. (MCHP) are climbing more than 10 percent or $9.86 in Wednesday's morning trade at $106.70 after the semiconductor company raised its outlook for the first quarter, saying its business was performing better than it expected during its May 7 earnings conference call.

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Significant Slowdown In Job Losses May Add To Economic Optimism

The major U.S. index futures are pointing to a higher open on Wednesday, with stocks likely to extend the upward trend seen in recent sessions.

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Lufthansa Q1 Loss Widens, Plans Restructuring; Sees Capacity Growth; Stock Up

Deutsche Lufthansa AG eported Wednesday sharply wider net loss in its first quarter with lower revenues as Covid-19 pandemic caused drastic decline in air travel. The German airline continues to expect a significant decline in fiscal 2020 adjusted EBIT. Further, the company said it expects capacity to increase from 3 percent of original planning in May to up to 40 percent in September.

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Campbell Soup Boosts FY20 Outlook - Quick Facts

While reporting financial results for the third quarter on Wednesday, Campbell Soup Co. (CPB) raised its adjusted earnings, net sales and organic sales growth guidance for the full-year 2020, to reflect improved outlook based on current operating environment and the performance in the third quarter, which was significantly impacted by the increase in demand of its products amidst the COVID-19 pandemic.

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AGEN, AGE To Battle Coronavirus, BCLI Awaits ALS Trial Data, FDA Delays Decision On NVS' Drug

Today's Daily Dose brings you news about Agenus' foray into COVID-19 drug development space; AMERI Holdings' progress in glioblastoma multiforme drug development; BrainStorm Cell's anticipated milestone related to its amyotrophic lateral sclerosis drug candidate; Citius Pharma's path forward for antibiotic lock solution; Novartis' revised FDA decision date and stock offerings of EvoFem and OraSure

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FDA Asks More Companies To Recall Diabetes Drug Metformin

Following the recall of type 2 diabetes medication Metformin Hydrochloride Extended-Release (ER) by Apotex last week, the U.S. Food and Drug Administration or FDA has recommended more pharmaceutical companies, who are manufacturers of the drug formulation, to recall their products.

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Tenax Therapeutics' Phase II Pulmonary Hypertension Trial Produces Mixed Results

Tenax Therapeutics Inc.'s (TENX) phase II trial, which evaluated Levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction, has produced mixed results.

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Agenus Says FDA Clears IND For Allogeneic INKT Therapy To Treat COVID-19 Patients

Immuno-oncology company Agenus Inc. (AGEN) announced Tuesday the FDA's clearance of AgenTus' IND application for an allogeneic iNKT therapy. AgenT-797 was submitted by AgenTus Therapeutics, a subsidiary of Agenus.

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Optimism About Economic Recovery Overshadows Social Unrest

The major U.S. index futures are currently pointing to a higher on Tuesday, with stocks likely to add to the gains posted in the previous session.

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Stock Alert: Tenax Shares Soar 72% In Premarket On Phase 2 Trial Results Of Levosimendan

Shares of Tenax Therapeutics Inc. (TENX) are surging over 72% in pre-market today, after the specialty pharmaceutical company announced positive Phase 2 results for levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction.

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Cracker Barrel Q3 Comp Sales Decline 41.7% Quick Facts

While reporting financial results for the third quarter on Tuesday, Cracker Barrel Old Country Store, Inc. (CBRL) reported that comparable store restaurant sales declined 41.7 percent and comparable store retail sales also decreased 45.5 percent from the prior year quarter.

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Donaldson Expects May Sales To Be Down 20% - Quick Facts

While reporting financial results for the third quarter on Tuesday, Donaldson Co. Inc. (DCI) said sales for the month of May 2020 is expected to down 20 percent, reflecting relative outperformance in replacement parts versus new equipment, and, on a regional basis, Asia Pacific sales are expected to be the strongest while sales in the Americas are expected to be the weakest.

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NTLA Gains On Amended REGN Deal, GILD Reports SIMPLE Results, MYOV On Watch, NVUS Slumps

Today's Daily Dose brings you news about Passport Health Plan failing to secure a new Medicaid managed care contract; Gilead's Remdesivir trial results in COVID-19 patients; Iterum missing trial goals in SURE2 study; Ocugen pulling the plug on ocular Graft vs. Host Disease; Novus' disappointing results in acute otitis media study.

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Stock Alert: Intellia, Regeneron Expand Collaboration; Shares Up 17% In Premarket

Shares of Intellia Therapeutics Inc. (NTLA) are rising over 17% in pre-market today, after the company announced that it expanded collaboration to provide Regeneron with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B.

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Traders May Take A Breather Following Recent Strength

The major U.S. index futures are currently pointing to a roughly flat opening on Monday, with stocks likely to show a lack of direction following the strong upward move seen in May.

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CTI BioPharma Enrolls First Patient In COVID-19 PRE-VENT Phase 3 Trial Of Pacritinib

CTI BioPharma Corp. (CTIC) said Monday it has enrolled the first patient in the Phase 3 PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19. The company expects to report topline data from the trial by the end of 2020.

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Eli Lilly Begins Phase 1 Study Of Potential COVID-19 Antibody

Eli Lilly and Company (LLY) said patients have been dosed in a Phase 1 study of LY-CoV555, the lead antibody from the company's collaboration with AbCellera, in COVID-19 treatment. The patients were dosed at major medical centers in the U.S. under a randomized, placebo-controlled, double-blind trial.

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Eli Lilly Says FDA OKs SBLA For Taltz Injection For Non-Radiographic Axial Spondyloarthritis

Eli Lilly and Co. (LLY) announced Monday that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.

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CytoDyn Files For FDA's Priority Review Designation For BLA For Leronlimab - Quick Facts

Biotechnology company CytoDyn Inc. (CYDY.OB) announced Monday that it has filed with the U.S. Food and Drug Administration (FDA) a request seeking Priority Review designation for its Biologics License Application (BLA) for leronlimab as a combination therapy for HIV indication.

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Stock Alert: Moderna Shares Up 4% In Premarket

Shares of Moderna Inc. (MRNA) are currently trading at $64.00, up $2.50 or 4.07% in the pre-market session. The stock has been trading in the range of $11.54 - $87.00 for the past one year, and closed Friday's trade at $61.50, up $5.96 or 10.73%.

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Karyopharm In Pursuit Of Wider Use Of Xpovio

After winning FDA nod for Xpovio in the treatment of relapsed or refractory multiple myeloma, Karyopharm Therapeutics Inc. (KPTI) is now awaiting the FDA decision on the same drug for another indication - i.e., in relapsed/refractory diffuse large B-cell lymphoma.

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