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The Daily Biotech Pulse: Mesoblast Slumps On FDA Rejection, AstraZeneca's Breakthrough Therapy Designation, 3 IPOs

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The Daily Biotech Pulse: Mesoblast Slumps On FDA Rejection, AstraZeneca's Breakthrough Therapy Designation, 3 IPOs

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 Oct. 1)

  • 10X Genomics Inc (NASDAQ: TXG)
  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) ( moved on M&A speculation)
  • Annexon Inc (NASDAQ: ANNX)
  • Axonics Modulation Technologies Inc (NASDAQ: AXNX)
  • Beigene Ltd (NASDAQ: BGNE)
  • BioLife Solutions Inc (NASDAQ: BLFS) (closed SciSafe buy)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI)
  • CareDx Inc (NASDAQ: CDNA) (announced Medicare reimbursement for AlloSure Heart, a donor-derived cell-free DNA test)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • LifeSci Acquisition Corp (NASDAQ: LSAC)
  • Myokardia Inc (NASDAQ: MYOK)
  • Novocure Ltd (NASDAQ: NVCR)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)
  • PPD Inc (NASDAQ: PPD)
  • Prelude Therapeutics Inc (NASDAQ: PRLD)
  • Qiagen NV (NYSE: QGEN)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • Shockwave Medical Inc (NASDAQ: SWAV)
  • Tcr2 Therapeutics Inc (NASDAQ: TCRR)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 1)

  • Aduro BioTech Inc (NASDAQ: ADRO)
  • Alector Inc (NASDAQ: ALEC)
  • Dyne Therapeutics Inc (NASDAQ: DYN)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
  • Outset Medical Inc (NASDAQ: OM)
  • PainReform Ltd (NASDAQ: PRFX)
  • Pandion Therapeutics Inc (NASDAQ: PAND)
  • Pliant Therapeutics Inc (NASDAQ: PLRX)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Recro Pharma Inc (NASDAQ: REPH)
  • SCYNEXIS Inc (NASDAQ: SCYX)
  • Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)
  • Taysha Gene Therapies Inc (NASDAQ: TSHA) (listed on Sept. 24)
  • Theravance Biopharma Inc (NASDAQ: TBPH)

Stocks In Focus

Mesoblast's Ryoncil Fumbles at Regulatory Hurdle

Mesoblast (NASDAQ: MESO) said the FDA issued a complete response letter to its BLA for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease. The FDA has sought the company conduct at least one additional study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

Mesoblast said it will urgently request a Type A meeting with the FDA, which could be held within 30 days, to discuss a potential accelerated approval, with a post-approval condition for an additional study.

The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity, the company said.

The stock was on a T1 trading halt Thursday. In after-hours trading, the stock slumped 42.83% to $10.61.

Sanofi's Regulatory Application For Enzyme Replacement Therapy For Pome Disease Accepted For Review In Europe

Sanofi SA (NASDAQ: SNY) said the EMA accepted for review the marketing authorization application for avalglucosidase alfa, as a long-term enzyme replacement therapy for the treatment of patients with Pompe disease. Avalglucosidase alfa is an investigational enzyme replacement therapy, which, if approved, would offer a potential new standard of care for patients with Pompe disease.

The company expects EU approval for the therapy in the second half of 2021.

AstraZeneca Farxiga Gets Breakthrough Therapy Designation

AstraZeneca plc (NASDAQ: AZN) said its Farxiga has been granted breakthrough therapy designation in the U.S. for patients with chronic kidney disease, with and without type 2 diabetes.

Metacrine To Present Positive Proof-of-concept For NASH Drug

Metacrine Inc (NASDAQ: MTCR) announced new pharmacokinetic and pharmacodynamic data from its MET409 Phase 1b proof-of-concept clinical trial in patients with non-alcoholic steatohepatitis, or NASH, showing robust and sustained FXR activation, which is expected to be key to optimizing therapeutic benefits.

"Combined with a favorable pharmacological and tolerability profile, these results further highlight the therapeutic potential of MET409 for patients with NASH," the company said.

The company is scheduled to present these findings as two posters at the American Association for the Study of Liver Diseases' The Liver Meeting Digital Experience scheduled between Nov. 13 and 15.

The stock rose 4.17% to $10.50 in after-hours trading.

Aduro's Shareholders Approve Merger Transaction With Chinook

Aduro BioTech Inc (NASDAQ: ADRO) said at a special meeting of shareholders held Oct. 1, its shareholders approved its proposed merger with Chinook Therapeutics.

Following stockholder approval, the company announced a one-for-five reverse stock split. The shares will begin trading on a split-adjusted basis on Nasdaq, effective with the open of the market Friday.

The closing of the merger is anticipated to on or around Oct. 5. Following closing of the merger, the combined company will be renamed Chinook Therapeutics and trade under the trading symbol KDNY, Aduro said.

The stock was up 4.20% to $2.98 in after-hours trading.

Lab Corp. Gets EUA For New Tech to Improve Speed and Efficiency of PCR Test to Detect COVID-19

Laboratory Corp. of America Holdings (NYSE: LH) said it received emergency use authorization from the FDA for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing. The advancement, the company said, will help improve the speed and efficiency of RT-PCR tests.

Clinical Readouts

Xencor Inc (NASDAQ: XNCR) will present initial data from its Phase 1 dose-escalation study of tidutamab in patients with neuroendocrine tumors.

IPOs

Exton, Pennsylvania-based Immunome, Inc., which uses its proprietary human memory B cell platform to discover and develop antibody therapeutics, priced its upsized initial public offering, or IPO, of 3.25 million shares of its common stock at $12, at the middle of the estimated price range of $11-$13. The offering is expected to raise gross proceeds of $39 million. The shares will begin trading on the Nasdaq under the ticker symbol IMNM.

Cancer immunotherapy company Oncorus, Inc. priced its 5.8-million-share IPO at $15 apiece, for raising gross proceeds of $87 million. The Cambridge, Massachusetts-based company had earlier estimated a price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol ONCR.

Watertown, Massachusetts-based C4 therapeutics, Inc. priced its upsized IPO of 9.6 million shares at $19, above the estimated price range of $16-$18. The biopharma that develops therapeutic candidates to destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases, said it expects to raise gross proceeds of $182.4 million from the offering. The shares will commence trading on the Nasdaq under the ticker symbol CCCC.

 

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