The Daily Biotech Pulse: Tiziana Snags A Patent Win, Decision Day For Nabriva And Evoke, 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 June 18)

• ADC Therapeutics SA ADCT
• Adverum Biotechnologies Inc ADVM
• Alpine Immune Sciences Inc ALPN( announced a licensing agreement with AbbVie Inc ABBV
• Amicus Therapeutics, Inc. FOLD
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• BioMarin Pharmaceutical Inc. BMRN
• BioXcel Therapeutics Inc BTAI
• Burning Rock Biotech Ltd BNR
• Castle Biosciences Inc CSTL
• Cytokinetics, Inc. CYTK
• DiaMedica Therapeutics Inc DMAC
• Fennec Pharmaceuticals Inc FENC
• Neoleukin Therapeutics Inc NLTX
• Neubase Therapeutics Inc NBSE
• Ocular Therapeutix Inc OCUL
• Ovid Therapeutics Inc OVID
• Passage Bio Inc PASG
• Pliant Therapeutics Inc PLRX
• Protagonist Therapeutics Inc PTGX
• Royalty Pharma plc RPRX (IPOed Monday)
• Sarepta Therapeutics Inc SRPT(announced a licensing agreement with Selecta Biosciences Inc SELB for licensing the latter's immune tolerance platform, ImmTOR for use in Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies)
• Tandem Diabetes Care Inc TNDM
• TELA Bio Inc TELA
• TFF Pharmaceuticals Inc TFFP
• Trevena Inc TRVN
• Zentalis Pharmaceuticals Inc ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 18)

• CALLIDITAS THER/S ADR CALT

Stocks In Focus

Mylan Wins Patent Lawsuit Against Biogen With Respect To Multiple Sclerosis Drug

Mylan NV MYL said the U.S. District Court for the Northern District of West Virginia ruled in its favor by invalidating Biogen Inc's BIIB Tecfidera patent, U.S. Patent No. 8,399,514, for lack of written description. Mylan noted that the patent pertains to methods of treating multiple sclerosis using a dose of 480 mg/day of dimethyl fumarate delayed release capsules, and would have disallowed generic competition until 2028.

With the patent win, Mylan is allowed to launch of its dimethyl fumarate product upon the receipt of FDA approval.

In pre-market trading Friday, Mylan shares were rising 2.27% to $16.70.

Assembly Biosciences Regains Rights To Gastrointestinal Programs After AbbVie Terminates Deal

Assembly Biosciences Inc ASMB said it will regain worldwide rights to all microbiome gastrointestinal programs, including ABI-M201 and ABI-M301, licensed under its collaboration agreement with AbbVie's Allergan. The development follows AbbVie deciding to terminate the R&D, collaboration and license agreement. This decision was not based on any efficacy, safety, or other data related to the collaboration programs, Assembly Biosciences said.

ABI-M201 is currently being evaluated in a Phase 1b trial in patients with mild to moderate ulcerative colitis and ABI-M301 is a preclinical program for Crohn's disease, the company said. The transition is expected to be completed in the fourth quarter of 2020.

In pre-market trading, Assembly Biosciences shares were rising 1.95% to $22.50.

Tiziana to Get Patent For Platform Technology For Oral Administration Of Fully Human Monoclonal Antibodies

Tiziana Life Sciences plc TLSA announced the United States Patent and Trademark Office has granted a patent covering its proprietary platform technology for the oral administration of Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies. The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for regulation of immune system, the company added. The patent will be issued by the USPTO June 23.

The stock rallied 16.09% to $7 in pre-market trading.

Roche Reports Positive Results For Late-Stage Prostate Cancer Study

Roche Holdings AG Basel ADR RHHBY said the phase 3 IPATential150 study that evaluated ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care plus placebo met its co-primary endpoint of radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer and whose tumours had PTEN loss.

The company said overall survival benefit and additional secondary endpoints are not yet mature and the trial will continue until the next planned analysis.

Endologix CFO Departs, Announces Interim CEO

Endologix, Inc. ELGX said its CFO Vaseem Mahboob,will leave the company, effective July 1, to take over as CFO of a private global healthcare company.

The company announced the appointment of Cindy Pinto, VP, Financial Planning & Analysis, as interim CFO in addition to her current responsibilities, and it also said it has initiated a search process for a permanent successor.

Miragen Appoints Pharma Industry Veteran As COO

Miragen Therapeutics Inc MGEN announced the appointment of Lee Rauch as Chief Operating Officer, effective immediately. Rauch, who has over 25 years of experience in the biotech and pharma industries, will report to the CEO and will be responsible for overseeing business development, licensing, partnerships, investor relations, corporate communications, intellectual property, and new product planning, the company said.

In pre-market trading, the stock was up 4.20% t $1.24.

Akebia Names David Spellman as CFO

Akebia Therapeutics Inc AKBA said David Spellman is joining Akebia as its new SVP, Chief Financial Officer and Treasurer, effective June 29, replacing Jason Amello, who has been serving in the position since 2013.

Dynavax Says Human Trial of COVID-19 Vaccine Using Its Adjuvant Initiated

Dynavax Technologies Corporation DVAX announced the first participants have been dosed in the Phase 1 clinical trial to evaluate Clover Biopharma's vaccine candidate to prevent COVID-19 that contains the Company's CpG 1018 adjuvant.

In pre-market trading, Dynavax shares were rising 9.30% to $6.70.

Earnings

Urovant Sciences Ltd UROV reported a net loss of $1.68 per share for its fiscal-year 2019 fourth quarter compared to a loss of 96 cents per share a year ago. This was wider than the consensus loss estimate of $1.24 per share.

The stock was down 3.48% to $11.10 in pre-market trading.

BioNano Genomics Inc's BNGO first-quarter revenues fell from $1.8 million in 2019 to $1.1 million in 2020. The net loss widened from $7.8 million to $10.5 million.

The stock was sliding 5.80% to 49 cents in pre-market trading.

On The Radar

PDUFA Dates

Nabriva Therapeutics PLC – ADR NBRV is knocking at the FDA altar for the second time for its investigational antibiotic contepo for treating complicated urinary tract infection. The company hinted at the decision being delayed due to the FDA requiring inspection of the facilities of third-party manufacturers in Europe.

Evoke Pharma Inc EVOK has a PDUFA date in the unfolding for its Gimoti to treat women with acute and recurrent diabetic gastroparesis.

IPOs

Repare Therapeutics Inc., a precision oncology company enabled by its proprietary synthetic lethality approach, priced its upsized initial public offering of 11 million shares of its common shares at $20 per share. Repare's common shares are expected to begin trading on the Nasdaq under the ticker symbol RPTX.

Forma Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, priced its IPO of 13.88 million shares at $20 per share. The shares are expected to begin trading on the Nasdaq under the ticker symbol FMTX.