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)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 18)

• CALLIDITAS THER/S ADR (NASDAQ:CALT)

Stocks In Focus

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

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

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

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 (OTC: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. (NASDAQ: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

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

Akebia Names David Spellman as CFO

Akebia Therapeutics Inc (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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

Evoke Pharma Inc (NASDAQ: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.