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

Down In The Dumps

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

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