The Daily Biotech Pulse: PhaseBio To Start Potential Pivotal COVID-19 Trial, Immunomedics CEO Quits, Tetraphase Receives Sweetened Offer

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 May 27)

• ADC Therapeutics SA ADCT (went public May 15)
• Aeglea Bio Therapeutics Inc AGLE
• argenx SE – ADR ARGX
• ChemoCentryx Inc CCXI
• Imara Inc NASDAQ: (IMRA)
• Immunovant Inc IMVT
• Mersana Therapeutics Inc MRSN (announced positive interim Phase 1 data for XMT-1536 in patients with ovarian cancer)
• Vermillion, Inc. VRML

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 27)

• Cumberland Pharmaceuticals, Inc. CPIX (announced publication of positive data for its antibiotic in treating bacteremia and endocarditis)
• Sonnet Biotherapeutics Holdings Inc SONN
• Teligent Inc (NEW JERSEY) TLGT

Stocks In Focus

PhaseBio Gets FDA Nod For Potentially Pivotal Trial Of COVID-19 Treatment

PhaseBio Pharmaceuticals Inc PHAS announced FDA authorization to proceed with VANGARD, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.

PhaseBio said it expects to begin dosing patients by the end of June and report trial results late in the fourth quarter of 2020.

The stock was jumping 54.3% to $6.82 in Thursday's premarket session.

Roche To Commence Late-Stage Study Of COVID-19 Combo Treatment Option With Gilead's Remdesivir

Roche Holdings AG Basel ADR Common Stock RHHBY announced the initiation of a global Phase 3 study to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc. GILD.

Roche aid it expects to enroll patients in the study in June, with the results likely to be available in the summer.

Separately, Roche announced European approval of a new, shorter 2-hour Ocrevus infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis.

Tetraphase Receives Sweetened Offer From Melinta After AcelRx's Revised Offer

Tetraphase Pharmaceuticals Inc TTPH said its board has received a revised proposal from Melinta amending its prior acquisition proposal. In light of the amended offer, Tetrephase said the Melinta offer is a superior offer.

Tetraphase said it has notified AcelRx Pharmaceuticals Inc ACRX of the amended Melinta proposal, the superior offer determination and its intention to consider changing its recommendation or terminating the AcelRx offer unless AcelRx proposes revisions to the terms on or prior to Monday, June 1.

This follows AccelRx sweetening its earlier offer to $30 million in stock and cash based on the AcelRx closing share price on May 22, plus an additional $14.5 million in contingent value rights payable in cash.
See also: The Week Ahead In Biotech: ASCO Presentations In The Spotlight

Aerpio To Collaborate With Quantum Leap In COVID-19 Drug Trial

Aerpio Pharmaceuticals Inc ARPO and Quantum Leap Healthcare announced an agreement to evaluate razuprotafib in a new randomized, investigational treatment arm in the I-SPY COVID Trial for the treatment of ARDS in adult patients with moderate-to-severe COVID-19.

The stock jumped 38.11% to $1.08 in after-hours trading.

I-Mab's Severe COVID-19 Treatment Candidate Found Safe, Well-Tolerated In Phase 1b/2 Study

I-Mab ADR IMAB announced interim results from a clinical study of TJM2 in patients with cytokine release syndrome associated with severe COVID-19, with the Part 1 portion of the study evaluating the safety and tolerability of TJM2 in a total of 24 patients who were randomized at a ratio of 1:1:1 to receive either a single dose of 3 mg/kg TJM2, a single dose of 6 mg/kg TJM2 or placebo, administered by intravenous infusion.

The company noted that a Data Monitoring Committee that evaluated data from Part 1 of the study concluded that it can commence the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in the severe COVID-19 patients.

The stock added 3.01% to $24.98 in after-hours trading.

New Immunomedics  CEO Quits Due To Coronavirus-Related Logistics Issues

Immunomedics, Inc. IMMU said CEO Harout Semerjian has decided to step down from his role effective immediately. Semeriian assumed the CEO role April 16 after his predecessor quit in the wake of a CRL for the company's lead antibody-drug conjugate sacituzumab govitecan and accusations regarding a data integrity breach.

The company said the move was precipitated by the unfortunate significant logistical obstacles presented by the COVID-19 pandemic, including Semerjian's ability to fully assume his duties as CEO.

Dr. Behzad Aghazadeh, executive chairman of Immunomedics, will continue to support the in an executive leadership role going forward, the company said.

The stock was down 1.96% to $33.50 in the premarket session. 

FDA Grants Moleculin's Pre-IND Meeting Request For Coronavirus Drug Candidate, Shares to Resume Trading

Moleculin Biotech, Inc., MBRX said the FDA has granted the company's request for a pre-IND meeting to provide guidance regarding its plan to study its drug candidate WP1122 in a clinical trial for patients with COVID-19.

The company said it plans to submit its IND application in the second half of the year, contingent on the guidance received from its pre-IND meeting with the FDA.

Moleculin said in a separate release that Nasdaq has said its shares, which have been halted since May 4 due to questions regarding accuracy of information in the marketplace about its drug candidate for coronavirus, will begin trading again Thursday.

Offerings

Iovance Biotherapeutics Inc IOVA said it intends to offer $500 million of its common stock, subject to market and other conditions, in an underwritten public offering. All of the shares in the offering are to be sold by the company.

The stock was down 12.05% to $33.50 in Thursday's premarket session.

BioCryst Pharmaceuticals, Inc. BCRX priced its underwritten public offering of 18.71 million shares at $4.50 per share. The company also said it is offering to certain investors pre-funded warrants to purchase up to an aggregate of 3.51 million shares of its common stock at $4.49 per pre-funded warrant.

The company expects to raise gross proceeds of $100 million from the offering.

The stock was down 7.25% at $4.67 premarket. 

Arena Pharmaceuticals, Inc. ARNA said it intends to offer in an underwritten public offering and subject to market and other conditions, $250 million worth of its common stock. All of the shares are being offered by the company.

Arena shares were down 12.45% at $50.90 premarket. 

Arcus Biosciences Inc RCUS said it has commenced an underwritten public offering of its common stock. All the shares in the offering will be sold by the company.

The stock was down 1.29% at $26.70 premarket Thursday.

On The Radar

Earnings

• Adverum Biotechnologies Inc ADVM (after the close)
• Geron Corporation GERN (after the close)

Related Link: Merck's Coronavirus Plan Of Attack: 2 Partnerships, M&A Deal Aimed At Treatment, Vaccine Development