TransMedics Boosts FY22 Guidance

 

• TransMedics Group Inc (NASDAQ: TMDX) posted a Q3 EPS loss of $(0.25), better than the consensus of $(0.41) and $(0.47) a year ago.

• Net revenue of $25.7 million increased 378% Y/Y, beating the consensus of $18.87 million.

• Net revenue included a favorable revenue impact of $1.4 million due to a change in estimate related to accrued clinical trial contra revenue.

• Revenue from customer sales was $24.3 million, a 349% increase primarily due to OCS Heart and OCS Liver, sales of which were driven by the company's National OCS Program.

• "We strongly believe we are in the early stages of capitalizing on the significant greenfield opportunity we have created in the transplant space. We now plan to leverage the solid foundation we established in 2022 to drive TransMedics into its next growth phase in 2023," said Waleed Hassanein, President & CEO.

• Guidance: TransMedics is updating FY22 revenue to $80-$85 million, up from prior guidance of $67-$75 million and the consensus of $75.66 million.

https://finance.yahoo.com/news/transmedics-clocks-small-expected-q3-114339274.html

MacroGenics update on Gilead collaboration, trials

 

• Collaboration with Gilead to develop bispecific antibodies, including MGD024, announced

• Planned initiation of Phase 2 portion of MGC018 TAMARACK study in prostate cancer by year-end

• Anticipated update on lorigerlimab (PD-1 × CTLA-4 bispecific DART® molecule) monotherapy clinical data in first quarter of 2023

• Conference call scheduled for today at 4:30 p.m. ET

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

https://finance.yahoo.com/news/macrogenics-provides-corporate-third-quarter-200100804.html

BioAtla outlines progress

 

• Mecbotamab vedotin (BA3011) Phase 2 part 1 interim results in NSCLC continue to show antitumor activity with additional patients enrolled
  
  

• BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) enrollment in Phase 2 part 2 of study anticipated to begin by year-end
  
  

• CAB-CTLA-4 (BA3071) Phase 1 study ongoing in tumor types responsive to CTLA-4 inhibition with first two cohorts completed without Dose Limiting Toxicities (DLTs) or Serious Adverse Events (SAEs) reported; third cohort (70mg) on-going with DLT observation period anticipated to conclude by year-end
  
  

• BA3182, CAB-EpCAMxCAB-CD3 bispecific T-cell engager (TCE) IND submission anticipated by year-end
  
  

• Cash balance of $178.1 million at quarter-end expected to provide funding into 2H24
  
  

• Management to host conference call and webcast today at 4:30 PM Eastern Time

Conference Call and Webcast Details
The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, November 3, 2022, at 4:30 pm Eastern Time. A live webcast may be accessed here: https://viavid.webcasts.com/starthere.jsp?ei=1572537&tp_key=6d10a8eb15. The conference call can be accessed by dialing toll-free (844) 826-3035. The passcode for the conference call is 10171336.

A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.

https://finance.yahoo.com/news/bioatla-reports-third-quarter-2022-200100189.html

Sanofi, Astra win EU approval for prevention of infant RSV

 The European Commission on Friday approved Sanofi and AstraZeneca's Beyfortus for the prevention of a common and highly contagious type of respiratory infections in infants.

The long-acting therapy, also known as nirsevimab, was given EU marketing authorisation for the prevention of disease from infections caused by the respiratory syncytial virus (RSV), Sanofi said in a statement.

In the United States, the product, in which Swedish Orphan Biovitrum also holds some rights, is still under regulatory review as a potential breakthrough therapy.

Beyfortus, given by intramuscular injection, was recommended for approval by the European Medicines Agency in September.

https://finance.yahoo.com/news/sanofi-astra-win-eu-approval-070000794.html

Iveric Submits 1st Part of NDA for Rolling Review

 IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first part of its New Drug Application (NDA) for rolling review of avacincaptad pegol (ACP, also known as Zimura®) a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). As previously announced, the Company received Fast Track designation from the FDA for ACP. Following receipt of the topline GATHER2 data, the Company shared the data with the FDA. Based on the pivotal clinical trials, GATHER1 and GATHER2, which both met their primary endpoint in slowing GA progression with statistical significance at the 12-month time point, the Company requested rolling submission of its planned NDA, which the FDA granted. As per the Company’s agreement with the FDA, the first part of the NDA, which included the complete ACP clinical data package, was successfully submitted earlier today.

https://finance.yahoo.com/news/iveric-bio-announces-submission-first-223000569.html

ImmunoGen positive business update

 Launch Preparations Completed Ahead of November 28, 2022 PDUFA Date

Presentations at ESMO, IGCS, and ESGO Highlight Mirvetuximab’s Potential to Become New Standard of Care and Combination Agent of Choice in FRα-Positive Ovarian Cancer

Initial Data from Pivotal Phase 2 CADENZA Study Demonstrated Encouraging Activity and Favorable Tolerability of Pivekimab Sunirine in Frontline BPDCN

Conference Call to be Held at 8:00 a.m. ET Today

ANTICIPATED UPCOMING EVENTS

• Obtain accelerated approval of mirvetuximab for FRα-positive platinum-resistant ovarian cancer.

• Present initial data from relapsed and frontline unfit AML expansion cohorts combining pivekimab, azacitidine, and venetoclax in an oral presentation at the 2022 American Society of Hematology (ASH) Annual Meeting in December.

• Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end.

• Publish SORAYA data and data on mirvetuximab in combination with bevacizumab in peer-reviewed journals.

• Submit data covering mirvetuximab monotherapy and mirvetuximab in combination with bevacizumab regimens for potential inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines by early 2023.

• Report top-line data for MIRASOL in early 2023.

• Present efficacy data from the SORAYA trial by sequence of treatment at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2022 and now expects:

• revenues between $80 million and $90 million;

• operating expenses between $320 million and $330 million; and

• cash and cash equivalents at December 31, 2022 to be between $230 million and $240 million.

Revenue guidance does not reflect potential product sales from mirvetuximab.

The increase in operating expense guidance is largely attributable to faster than expected hiring, preparation for commercialization, and strong clinical trial startup and execution.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

https://finance.yahoo.com/news/immunogen-reports-recent-progress-third-103000513.html

BioNTech stock surges after report China agrees to approve its COVID vaccine for foreigners

 Shares of Germany-based BioNTech SE surged 5.1% toward a three-month high in premarket trading Friday, after The Wall Street Journal reported that China agreed to approve the biotechnology company's COVID-19 vaccines for foreign residents in China. Pfizer Inc.'s stock climbed 1.5% ahead of the open, as BioNTech had partnered with the U.S. drug giant to develop COVID-19 vaccines. China's agreement was announced by German Chancellor Olaf Scholz in a news conference in Beijing, after he met with Chinese leader Xi Jinping, the WSJ report said. The report comes as Bloomberg reported that China was looking at easing COVID travel restrictions. BioNTech shares have tumbled 19.5% over the past three months through Thursday and Pfizer's stock has lost 6.6%, while the S&P 500 has shed 10.4%.

https://www.morningstar.com/news/marketwatch/20221104240/biontech-stock-surges-toward-3-month-high-after-report-china-agrees-to-approve-its-covid-vaccine-for-foreigners