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The Daily Biotech Pulse: Safety Scare For Anaptys' Psoriasis Drug, NewLink Genetics To Merge With Lumos, Insider Buy Props Up VBI Vaccines

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The Daily Biotech Pulse: Safety Scare For Anaptys' Psoriasis Drug, NewLink Genetics To Merge With Lumos, Insider Buy Props Up VBI Vaccines

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs Sept. 30.)

  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
  • Celgene Corporation (NASDAQ: CELG)
  • Dova Pharmaceuticals Inc (NASDAQ: DOVA) (announced a deal to be acquired for up to $915 million)
  • GlaxoSmithKline plc (NYSE: GSK) (reacted to Phase 3 data for drug to treat ovarian cancer presented at ESMO 2019)
  • Insulet Corporation (NASDAQ: PODD)
  • Seattle Genetics, Inc. (NASDAQ: SGEN) (moved on ESMO 2019 presentations)

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 30.)

  • Aevi Genomic Medicine Inc (NASDAQ: GNMX)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO) (reacted to ESMO 2019 presentation)
  • Akcea Therapeutics Inc (NASDAQ: AKCA)
  • Alkermes Plc (NASDAQ: ALKS)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • AnaptysBio Inc (NASDAQ: ANAB)
  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • BioCardia Inc (NASDAQ: BCDA)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)
  • Calithera Biosciences Inc (NASDAQ: CALA)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • Catalyst Biosciences Inc (NASDAQ: CBIO)
  • Clovis Oncology Inc (NASDAQ: CLVS) (reacted to ESMO 2019 presentation)
  • Concert Pharmaceuticals Inc (NASDAQ: CNCE)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (reacted to ESMO 2019 presentation)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • IGM Biosciences Inc (NASDAQ: IGMS) (went public Sept. 18)
  • Inflarx NV (NASDAQ: IFRX)
  • Intra-Cellular Therapies Inc (NASDAQ: ITCI)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
  • Leap Therapeutics Inc (NASDAQ: LPTX)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB) (announced a restructuring plan)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Neuronetics Inc (NASDAQ: STIM)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)
  • ProQR Therapeutics NV (NASDAQ: PRQR)
  • Retrophin Inc (NASDAQ: RTRX)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Tocagen Inc (NASDAQ: TOCA)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • VBI Vaccines Inc (NASDAQ: VBIV)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Zosano Pharma Corp (NASDAQ: ZSAN)

Stocks In Focus

Anaptys Bio's Psoriasis Trial Shows Potential Drug-Related Serious Adverse Event

Anaptys Bio announced topline results from the interim analysis of the Phase 2 GALLOP study of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis that generated concerns over the safety of the drug.

The study, conducted with the first two patients, showed that both patients achieved the primary endpoint of improvement in the clinical global impression scale at day 29 and day 113 with no rescue therapy warranted. The rapid and sustained disease score improvement was observed in both patients, the company said. 

Yet one patient dropped out of the trial due to staphylococcal infection on day 3, which was a serious adverse event deemed to be drug-related.

The stock was down 8.6% at $31.98 in Tuesday's premarket session. 

See also: The Week Ahead In Biotech (Sept. 29-Oct. 5): Conference Presentations, IPOs Hit Top Gear

NewLink Genetics, Lumos To Merge 

NewLink Genetics Corp (NASDAQ: NLNK) announced a definitive merger agreement under which it will combine with privately held Lumos. NewLink said it will issue Lumos shareholders its common stock in exchange for their shares in Lumos, with the result being that Lumos shareholders will own about 50% of NewLink.

Following the merger, Lumos will become a wholly owned subsidiary of NewLink, and NewLink will be renamed as Lumos Pharma and trade on the Nasdaq under the ticker symbol "LUMO."

The deal is expected to close in the first quarter of 2020. In conjunction with the transaction, the combined company is planning to enact a reverse stock split.

NewLink Genetics shares rose 6.92% to $1.70 in the premarket session. 

Geron's Imetelstat Snags Fast Track Designation 

Geron Corporation (NASDAQ: GERN) said the FDA has accorded Fast Track designation to imetelstat for the treatment of adult patients with intermediate-2 or high-risk myelofibrosis whose disease has relapsed after — or is refractory to — janus kinase inhibitor treatment, or relapsed/refractory myelofibrosis.

The company said it plans to conduct an end-of-the-Phase 2 meeting with the FDA by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in the indication.

The stock was trading 12.03% higher to $1.49 in the premarket session. 

VBI Vaccines CEO Buys 150K Shares

Shares of VBI Vaccines, which are trading at a multiyear low, could receive a boost after CEO Jeff Baxter disclosed in a filing that he purchased 150,000 shares at an average price of 50.3 cents per share.

The stock was up 6.11% at 50 cents in the premarket session. 

Chimerix Out-Licenses Investigational Antiviral Medication For Up To $185M

Chimerix Inc (NASDAQ: CMRX) announced an exclusive global license agreement with SymBio Pharma Ltd, under which the latter receives worldwide rights to develop, manufacture and commercialize Chimerix's brincidofovir in all human indications, excluding the prevention and treatment of smallpox.

The agreement provides for Chimerix receiving an upfront payment of $5 million, plus potential clinical, regulatory and commercial milestones of up to $180 million. Chimerix is also eligible to receive double-digit royalties on net sales of brincidofovir worldwide.

The stock was down 1.28% to $2.32 in the premarket session. 

Eisai-Merck's Combo Therapy Found Effective In Advanced Endometrial Cancer

Eisai Co., Ltd (OTC: ESALY) and Merck & Co., Inc. (NYSE: MRK) presented at the ESMO 2019 with final results from the full endometrial cancer cohort of KEYNOTE-146/Study 111 evaluating Lenvima, an orally available kinase inhibitor with Keytruda, showing that the combo therapy showed an objective response rate, or ORR, at week 24 of 38%.

At the data cutoff date, the overall ORR was 38.9%, with a complete response rate, or CR, of 7.4% and a partial response, or PR, rate of 31.5%.

In 94 patients with tumors that weren't microsatellite instability high, or MSI-H, or mismatch repair deficient, or dMMR, the combo showed ORR of 37.2%, with a CR rate of 7.4% and a PR rate of 29.8% at the data cutoff date. 

Yet in the 11 patients who were MSI-H or dMMR, the ORR was 63.6%, with a CR rate of 9.1% and a PR rate of 54.5%.

On The Radar

Clinical Trial Readouts

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) is scheduled to release Phase 1 data for PRS-060 in asthma at the European Respiratory Society 2020 International Congress in Madrid, Spain.

Minerva Neurosciences Inc NASDAQ: NERV) will release Phase 2 update for MIN-202 vs. quetiapine in major depressive disorder, a Phase 3 update on roluperidone in schizophrenia and a Phase 2 update on MIN-117 in major depressive disorder.

Related Link: Movers And Shakers At ESMO 2019: Immunomedics, G1 Therapeutics, Seattle Genetics And More

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