Daily Biotech Pulse: Chiasma To Join R3K Index, EU Rejects Amgen's Osteoporosis Drug Application, Karuna IPO

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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 on June 27)

  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) (received fast track designation for its RNAi therapeutic for rare genetic liver disease associated with alpha-1 antitrypsin deficiency)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • Ra Pharmaceuticals Inc (NASDAQ: RARX)
  • Repligen Corporation (NASDAQ: RGEN)
  • Zai Lab Ltd (NASDAQ: ZLAB)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on June 27)

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  • Acer Therapeutics Inc (NASDAQ: ACER)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS) (said its hair loss drug candidate did not meet primary or secondary endpoints)
  • Caladrius Biosciences Inc (NASDAQ: CLBS)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • MOTIF BIO PLC / S ADR (NASDAQ: MTFB)
  • Neurometrix Inc (NASDAQ: NURO) (announced a strategic update in which it divulged plans to carry out restructuring)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • VERONA PHARMA P / S ADR (NASDAQ: VRNA)
  • Zafgen Inc (NASDAQ: ZFGN)

Stocks In Focus

On The Radar

Chiasma To Join the Broader Russell 3000 Index

Chiasma Inc (NASDAQ: CHMA) announced it has been selected for inclusion in the broad-based Russell 3000 Index, effective July 1. The inclusion increases the company's visibility among institutional investors.

Separately, the company issued a clinical trial update, suggesting that it expects to release top-line data that evaluates its evaluation Mycapssa as a maintenance treatment for adults with acromegaly by the middle of the third quarter. If positive, the company said the data will support an NDA filing later this year.

The stock rose 2.55% in after-hours trading.

EU Rejects Marketing Application For Amgen's Osteoporosis Drug

Amgen, Inc. (NASDAQ: AMGN) and Euronext Brussels-listed UCB said the companies have been informed by the Committee for Medicinal Products for Human Use, or the European Medicines Agency has adopted a negative opinion on the Marketing Authorization of their co- promoted Evenity for the treatment or severe osteoporosis.

The companies will now submit a written notice for a reexamination by the CHMP.

FDA approval for the treatment of osteoporosis in postmenopausal women at high risk for fracture

Progenics Continues To Bicker With Activist Investor Velan

Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) filed with the SEC the efforts it has taken to settle with its biggest shareholder Velan Capital L.P., which has taken up cudgels against the company demanding changes. The company said Velan has rebuffed its reasonable offer which included a year standstill, designating two new directors and incumbent direction not standing for re-election in 2020.

The company said it is willing to reach a solution in the best interest of all shareholders.

In response, Velan said Progenics' board is taking its responsibility by not cooperating with its requests for two non-voting boards.

Sorrentio To Offer Shares And Warrants To Purchase Shares

Sorrento Therapeutics Inc (NASDAQ: SRNE) intends to offer and sell, shares of common stock and series, A, B and C warrants to purchase shares of its common stock in an underwritten public offering. The company said it intends to use the net proceeds for its clinical development of its RTX, CEA, CAR-T and CD38 CAR-T programs among other things.

Arcturus' Inherited Metabolic Disorder Gets Orphan Drug Designation

Arcturus Therapeutics Ltd (NASDAQ: ARCT) said the FDA has granted Orphan Drug Designation for its lead product candidate ARCT-810 to treat ornithine transcarbamylase deficiency – the most common urea cycle disorder which makes it difficult to remove toxic products as proteins are digested.

The stock climbed 0.72% to $ 9.75 in after-hours trading.

Clinical Trial Readouts

Scholar Rock Holding Corp (NASDAQ: SRRK) is two to release final Phase 1 data for its spinal muscular atrophy drug candidate SRK-015 at the Cure SMA Annual Conference.

Pfizer Inc. (NYSE: PFE) will release Phase 1b data for PF-06939926 in Duchenne muscular dystrophy at the Parent Project Muscular Dystrophy Conference 2019 Annual Conference.

IPOs

Karuna Therapeutics, which develops therapies for schizophrenia and other central nervous system disorders, priced its upsized offering of 5,578 million shares at $ 16 per share, which is the mid-point of the estimated price range of $ 15- $ 17. The company will list its shares on the Nasdaq under the ticker symbol KRTX.

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