The Daily Biotech Pulse: Setback For Alkermes, Boston Scientific's Recall, ALX-Zymeworks Oncology Collaboration

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Nov. 16)

• Aligos Therapeutics Inc ALGS (announced multiple presentations at the Liver Meeting)
• Amicus Therapeutics, Inc. FOLD
• Atara Biotherapeutics Inc ATRA
• Champions Oncology Inc CSBR
• CureVac BV CVAC(announced a vaccine supply deal with the European Commission)
• Eidos Therapeutics Inc EIDX
• Generation Bio Co GBIO
• Immunovant Inc IMVT
• Infinity Pharmaceuticals Inc. INFI
• Intellia Therapeutics Inc NTLA
• Kazia Therapeutics Ltd KZIA
• Keros Therapeutics Inc KROS
• Moderna Inc MRNA ( announced positive interim efficacy data for the Phase 3 study of its coronavirus vaccine candidate)
• Myokardia Inc MYOK
• Neuronetics Inc STIM
• Ocular Therapeutix Inc OCUL
• Oncorus Inc ONCR
• Pacira Biosciences Inc PCRX
• Shockwave Medical Inc SWAV
• Spruce Biosciences Inc SPRB
• Summit Therapeutics Inc SMMT
• Syndax Pharmaceuticals Inc SNDX
• Tcr2 Therapeutics Inc TCRR
• TRACON Pharmaceuticals Inc TCON (announced regulatory filing for envafolimab in the indication of MSI-H/dMMR cancer, in China)
• Trinity Biotech plc TRIB
• United Therapeutics Corporation UTHR
• Veracyte Inc VCYT
• Vericel Corp VCEL
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 16)

• 180 Life Sciences Corp ATNF
• Jaguar Health Inc JAGX
• Kiromic Biopharma Inc KRBP
• PMV Pharmaceuticals Inc PMVP

Stocks In Focus

Bristol-Myers Squibb Announces Delay In Regulatory Review Period For Lymphoma Treatment Candidate

Bristol-Myers Squibb Co BMY said the FDA has informed it that its review of the BLA for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies will not be completed by the PDUFA action date of Nov. 16. This is due to the agency's inability to inspect a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic.

The FDA did not provide a new anticipated action date.

Alkermes Schizophrenia Drug Fails to Win FDA Nod

Alkermes Plc ALKS said the FDA has issued a complete response letter regarding its new drug application for ALKS 3831 for the treatment of adults with schizophrenia and adults with bipolar I disorder.

"Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved," the company said.

The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

ALX, Zymeworks Announce Collaboration to Study Oncology Drug Combination In Breast Cancer, Solid Tumors

ALX Oncology Holdings Inc ALXO and Zymeworks Inc ZYME said they have entered into a clinical collaboration to evaluate the combination of Zymeworks' zanidatamab, a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors.

The agreement provides for Zymeworks conducting a Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study. The first part of the trial will evaluate the safety of the combination treatment. The second part of the trial will evaluate the safety, tolerability and anti-tumor activity of the combination in separate cohorts of subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.

RA Medical to Being Trading On Reverse Split-adjusted Basis

RA Medical Systems Inc RMED said its 1-for-25 reverse stock split will become effective at 5:00 pm, Nov. 16. The shares will begin trading on a split-adjusted basis on the NYSE, beginning Nov. 17

The stock plunged 14.23% to 18 cents in after-hours trading.

Boston Scientific Voluntarily Recalls Aortic Valve System, to Discontinue The Product

Boston Scientific Corporation BSX said it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve, the company said.

Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company said it has chosen to retire the entire LOTUS product platform immediately.

The company expects to incur total pre-tax GAAP charges of approximately $225 million to $300 million related to the decision, with $100 million to $150 million likely to affect adjusted results.

Earnings

Summit Therapeutics Inc SMMT reported third-quarter revenues of $181,000 in 2020 compared to 148,000 in 2019. The net loss per share widened from 20 cents to 26 cents, while analysts estimated a loss of 1 cent per share. The company also said it is withdrawing the timeline it had earlier publicly declared for the completion of the Phase 3 Ri-CoDIFy trials of ridinilazole in C. difficile infection.

The stock slipped 14.46% to $4.20 in after-hours trading.

PLx Pharma Inc PLXP reported no revenues for the third quarter of 2020 compared to $41,106 million in the year-ago period. The company reversed to a loss of 40 cents from a profit of 9 cents. Analysts had estimated a wider loss of 42 cents per share,

The company also said it has submitted two chemistry and manufacturing control supplemental new drug applications one for VAZALORE 325 mg and one for VAZALORE 81 mg dose to the FDA in October for regulatory approval.

The stock moved down 8.03% to $4.01 in after-hours trading.

Co-Diagnostics Inc's CODX reported below-consensus third-quarter EPS despite a strong increase in revenues.

Separately, the company announced CE mark approval for Logix Smart ABC (Influenza A/B, SARS-CoV-2) and its Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex test for multiple targets of the SARS-CoV-2 genome.

In premarket trading, the stock was down 16.11% to $11.40.

On The Radar

Clinical Readouts/Presentations

Avrobio Inc AVRO will announce at its Virtual R&D Day additional details on its new Hunter syndrome program, while also sharing new data on its three clinical programs, including initial clinical data from its Gaucher disease program.

Earnings

Trinity Biotech plc TRIB (before the market open)
PAVmed Inc PAVM