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 17)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 17)

Stocks In Focus

FDA Authorizes Roche COVID-19 Test For Emergency Use In Asymptomatic Individuals

Roche Holding AG (OTC:RHHBY) said the FDA has issued emergency use authorization for its cobas SARS-CoV-2 Test for use on the widely available, high-throughput cobas 6800/8800 Systems for testing individuals without symptoms or reasons to suspect COVID-19.

This authorization supports the guidance update from the U.S. Centers for Disease Control and Prevention to expand SARS-CoV-2 testing to include people without symptoms in an effort to reduce the spread of disease.

Stealth To Get Additional $30M Funding For Elamipretide Trials

Stealth BioTherapeutics Corp (NASDAQ:MITO) announced that it has reached an agreement with Morningside Ventures for providing $30 million of additional payments to the company during 2021 under its existing development funding agreement.

The additional payments were triggered by new, positive analysis of clinical data from the ReCLAIM Phase 1 trial, announced in early March, which associated baseline mitochondrial viability with improvements in vision for patients with geographic atrophy.

"This additional funding will allow us to initiate a Phase 3 clinical trial evaluating the impact of elamipretide in patients with nPMD as well as continue our work on an intravitreal formulation to inform Phase 3 formulation decisions as we await data from our ongoing ReCLAIM-2 trial in geographic atrophy early next year," said Reenie McCarthy, CEO of Stealth.

The stock rose 9.24% to $1.30 in after-hours trading.

Lilly's Regulatory Filing For Lung Cancer Combo Therapy Accepted For Review

Eli Lilly and Company (NYSE:LLY) said the FDA accepted for review a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer.

This is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.

Related Link: The Week Ahead In Biotech: Sanofi, Bristol-Myers Squibb Await FDA Decisions, Earnings News Flow Tapers Off

BioNTech Appoints Morphosys Executive as CFO

BioNTech SE (NASDAQ:BNTX) appointed Jens Holstein as its CFO, with Holstein taking over from Dr. Sierk Poetting, who will fully focus on his tasks as chief operating officer going forward.

Holstein previously served as CFO for MorphoSys AG (NASDAQ:MOR) and in various CFO and general management roles within the Fresenius SE Group.

Shares of the COVID-19 vaccine company were down 0.5% at $197.30.

GlaxoSmithKline, Partner Medicago Report Positive Phase 2 Data For Plant-Derived COVID-19 Vaccine

GlaxoSmithKline plc (NYSE:GSK) and Medicago reported positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago's plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK's pandemic adjuvant.

Immunogenicity, as measured by the neutralizing antibody titer, was about 10 times higher than those in a panel of sera from patients recovering from COVID-19. No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.

The Phase 3 trial of the vaccine candidate was launched in mid-March.

AstraZeneca Commits To Procure Additional COVID-19 Vaccine Doses From Oxford BioMedica

Oxford Biomedica raised its revenue guidance for expected cumulative revenues from AstraZeneca by the end of 2021 from in excess of 50 million pounds to in excess of 100 million pounds.

PacBio Announces Appointment Of 3 Execs

Pacific Biosciences of California, Inc. (NASDAQ:PACB) announced the appointment of three new hires, with Dr. Catherine Ball joining as SVP of research. Kathleen Lynch joins as head of global government affairs and corporate communications and Michele Farmer has been appointed as chief accounting officer.

The stock was up 0.47% to $23.50 in after-hours trading.

Spero Gets Upto $21.3M In NIAID Funding For SPR206

Spero Therapeutics, Inc. (NASDAQ:SPRO) said it has been awarded funding of $2.09 million, with the potential for up to an additional $21.3 million over five years, from the NIAID.

The funding will support the further clinical development of SPR206, an intravenously administered, next-generation polymyxin product candidate derived from Spero's potentiator platform that is being developed to treat serious multi-drug resistant Gram-negative infections in the hospital setting.

The stock added 1.87% to $13.65 in after-hours trading.

Summit Selects New Preclinical Candidate For Multidrug-Resistant Infections, Gets Up To $7.8M In Financing

Summit Therapeutics Inc. (NASDAQ:SMMT) announced that it has selected a new preclinical candidate, SMT026738, for development against multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae infections.

Simultaneously, Summit has also received an award from CARB-X to progress this candidate through preclinical development and Phase 1a clinical trials. The award commits initial funding of up to $4.1 million, with the possibility of up to another $3.7 million based on the achievement of future milestones.

The stock was down 1.46% to $6.75 in premarket trading Tuesday.

Offerings

Clovis Oncology, Inc. (NASDAQ:CLVS) said it has filed a prospectus supplement with the U.S. SEC, under which it may offer and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75 million through an at-the-market equity offering program.

The stock shed 3.75% to $5.65 in after-hours trading.

Evofem Biosciences, Inc. (NASDAQ:EVFM) said it intends to offer and sell in an underwritten public offering, subject to market and other conditions, shares of its common stock, or pre-funded warrants to purchase common stock in lieu of common stock, in an underwritten public offering.

Each share of common stock or pre-funded warrant will be sold with a common warrant to purchase one share of common stock. All of the shares of common stock, pre-funded warrants and common warrants to be sold in the offering are to be offered by Evofem.

The stock slumped 24.22% to 97 cents in after-hours trading.

Earnings

Vivos Therapeutics, Inc.'s (NASDAQ:VVOS) first-quarter revenue rose 8% year-over-year to $3.4 million. The net loss per share grew from 19 cents to 23 cents. Analysts, on average, estimated a loss of 17 cents per share on revenues of $3.25 million.

In after-hours session, the stock declined 9.24% to $5.50.

Aytu Biopharma, Inc. (NASDAQ:AYTU) reported third-quarter net income of $13.5 million, up from $8.2 million a year ago. The net loss per share narrowed from $1.51 to $1.41, while analysts estimated a loss of 31 cents per share.

The stock fell 6.24% to $5.26 in after-hours trading.

On The Radar

Clinical Readouts

CytoDyn Inc. (OTC:CYDY) will provide an update on ongoing work with the FDA and other regulatory agencies on using sub-population data to ensure future adequate trial design in order to continue to further its clinical development of leronlimab in the treatment of patients with COVID-19.

The company will also provide further clarification on the secondary endpoints met in the critically ill pre-specified sub-population.

The FDA earlier issued a statement that said, with the conclusion of both the CD10 and CD12 clinical trials by CytoDyn, it has become clear the available data does not support the clinical benefit of leronlimab for the treatment of COVID-19.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates