Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Merck Commences Late-Stage Study Of Heart Failure Treatment
Merck & Co., Inc. MRK announced the initiation of VICTOR, a pivotal Phase 3 cardiovascular clinical trial of Verquvo in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event.
Gilead's Partner Announces Positive Phase 2b Data For Antibody-Drug Conjugate In Breast Cancer Study In China
Gilead, Inc. GILD and Everest Medicines announced that Everest Medicines' Phase 2b EVER-132-001 study of sacituzumab govitecan, marketed as Trodelvy in the U.S., met its primary endpoint of overall response rate in metastatic triple-negative breast cancer.
EVER-132-001 is a single-arm, multi-center Phase 2b registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China.
Neuropace's Proprietary RNS System Gets Investigational Device Exemption For Treating Epilepsy
Neuropace, Inc. NPCE announced that it has received an investigational device exemption from the U.S. Food and Drug Administration to study its proprietary RNS System in patients with drug-resistant idiopathic generalized epilepsy.
Koru Medical Gets FDA Clearance For Hizentra Prefilled Syringes
KORU Medical Systems KRMD announced 510k clearance for use of the KORU Medical FreedomEdge infusion pump to deliver Hizentra, 20 mL prefilled syringes. Hizentra is a subcutaneous Ig product to be available in a prefilled syringe format.
Separately, the company reported nearly flat revenues for its third quarter and its bottom-line results showed a loss of 2 cents per share, reversing from a profit of 1 cent per share.
The stock was up 10.64% at $3.12 in premarket trading.
Related Link: The Week Ahead In Biotech (Nov. 7-Nov. 13): Earnings Taper Off, Multiple Conference Presentations, IPOs And More
Eisai, Biogen Presents Positive Data From Phase 2b Open-Label Studies of New Alzheimer's Treatment
Eisai Co., Ltd. ESALY and Biogen, Inc. BIIB announced results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer's disease from the lecanemab Phase 2b 201 and the open-label extension studies.
The findings, presented in a late-breaking roundtable session with clinical researchers at the 2021 Clinical Trials on Alzheimer's Disease conference, showed treatment with lecanemab resulted in reduction of brain amyloid levels in as early as three months and robust clearance of amyloid plaque with more than 80% of participants achieving amyloid negative status by 12-18 months of treatment as measured by PET.
Eisai recently initiated a rolling submission of a biologics license application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease.
Biogen shares were up 1.09% at $269.83 in premarket trading.
Humanigen To Study Lenzilumab In Acute Graft Versus Host Disease In Collaboration With UK University
Humanigen, Inc. HGEN said it plans to support a Phase 2/3 study to evaluate lenzilumab for the early treatment of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation in collaboration with IMPACT, an accelerated trial network delivering innovative research for stem cell transplant patients in the U.K.
The safety run-in component of the RATinG study is anticipated to be completed in 2022. The study is partially funded by IMPACT with Humanigen providing lenzilumab and the remaining funding for the study.
Recently, the company faced a setback when the FDA declined its request for emergency use authorization of its lenzilumab drug to treat newly hospitalized COVID-19 patients.
Sight Sciences' Intraocular Pressure Lowering OMNI Device Gets Investigational Device Exemption
Sight Sciences, Inc. SGHT announced the FDA has granted an investigational device exemption authorizing the company to conduct a clinical study to assess the safety and effectiveness of a new, higher volume investigational OMNI device to perform canal viscodilation alone to lower intraocular pressure in adults with primary open-angle glaucoma.
In premarket trading, the stock was gaining 10.24% to $26.71.
Soi Gene Announces Successful Manufacture Of Parkinson's Disease Gene Therapy Candidate
Sio Gene Therapies Inc. SIOX said it has completed three successful GMP campaigns for AXO-Lenti-PD, its clinical-stage gene therapy for Parkinson's disease, using a suspension-based manufacturing process, with all batches achieving target titers and successfully completing fill and finish.
The company said it is on track to get qualified person certification of at least one batch of clinical trial material in the fourth quarter. It has also obtained scientific advice from the Medicines and Healthcare Products Regulatory Agency in the U.K. regarding continued clinical development
The company said it expects to provide program update in the first quarter of 2022.
The stock was advancing 5.18% to $2.03 in premarket trading.
Gamida Cell Announces Delay In Regulatory Filing For Blood Cancer Treatment Candidate
Gamida Cell Ltd. GMDA said it has completed a Type B Pre-BLA meeting with the FDA for omidubicel, a treatment candidate for patients with blood cancers in need of stem cell transplant. The FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at its wholly owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study.
The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. The company will continue to work collaboratively with the FDA and anticipates submitting the BLA in the first half of 2022 in lieu of the company's previous plan to submit the BLA by the end of 2021.
The stock was slipping 3.03% to $3.84 in premarket trading.
Compugen Announces Completion of $20M Bristol-Myers Squibb Investment
Compugen Ltd. CGEN announced today that Bristol Myers Squibb BMY completed its $20-million investment in Compugen in consideration for the issuance of 2.333 million shares of Compugen purchased at $8.57333 per share, representing a 33% premium over the closing price on Nov. 9.
Compugen stock was up 18.95% at $7.47 in premarket trading.
TherapeuticsMD Elevates Hugh O'Dowd As CEO, Reports Q3 Miss
TherapeuticsMD, Inc. TXMD announced the appointment of Hugh O'Dowd, its current president, as the chief executive officer and member of the board of directors. O'Dowd will succeed Robert Finizio, the company's co-founder and current CEO, effective on or before Dec. 31. Finizio will continue with the company and has been appointed vice chair of the board.
Separately, the company announced a wider-than-expected loss and below-consensus revenues for the third quarter.
Earnings
Progenity, Inc. PROG reported a steep decline in third-quarter revenues from $36.1 million to $9.6 million. The net loss per share, however, narrowed from $1.23 to 46 cents.
The stock was slipping 5.4% to $3.33 in premarket trading.
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On The Radar
14th CTAD Meeting Presentations
Cortexyme, Inc. CRTX: topline results from the Phase 2/3 study of Atuzaginstat in mild to moderate Alzheimer's disease
Earnings
Sol-Gel Technologies Ltd. SLGL (before the market open)
Aptose Biosciences Inc. APTO (after the close)
Apyx Medical Corporation APYX (after the close)
BioLife Solutions, Inc. BLFS (after the close)
Eledon Pharmaceuticals, Inc. ELDN (after the close)
IPOs
Tivic Health Systems, Inc. TIVC, a commercial-phase bioelectronic medicine company, priced its initial public offering of 3 million shares of its common stock at $5 per share, for gross proceeds of $15 million. All of the shares of common stock are being offered by the company. The shares will begin trading on the Nasdaq under the ticker symbol TIVC.
Dallas, Texas-based Vaxxinity VAXX, a biotech company with a proprietary platform is designed to harness the immune system to convert the body into its own drug factory, priced its downsized IPO of 6 million shares of its Class A common stock at $13, lower than the estimated price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol VAXX.
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
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