AstraZeneca's Enhertu Approved in US for Metastatic Breast Cancer

 AstraZeneca PLC said on Thursday that its metastatic breast cancer treatment Enhertu has been approved for use in the U.S.

The Anglo-Swedish pharma giant said Enhertu will be used in patients with breast cancer that were treated with a prior treatment and have developed disease recurrence during or within six months of completing therapy.

The company said clinical studies showed that the treatment has reduced the risk of disease progression or death by 72% when compared with other treatment.

Enhertu its a jointly treatment developed and commercialized by AstraZenecaa and Daiichi Sankyo Co.

Astrazeneca said regulatory applications are currently under review in Europe, Japan and several other countries.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-s-Enhertu-Approved-in-US-for-Metastatic-Breast-Cancer-Treatment-40276794/

Hikma drops on slashing generics unit forecasts

 Hikma Pharmaceuticals Plc cut annual sales and margin forecasts for its second-biggest unit on Thursday, due to possible delays in the launch of a generic version of a sleep disorder treatment, sending its shares tumbling about 10%.

The London-listed drugmaker now expects revenue from its generics unit to be between $710 million and $750 million for 2022, with core operating margin of around 20%.

The revised outlook comes in stark contrast to the company's trading statement last week, when it had forecasted revenue from the business to grow 8% to 10% over 2021 sales of $820 million and predicted core operating margin in the range of 24% to 25%.

FTSE 100-listed shares of Hikma, which supplies many generic drugs including pain medications, anaesthetics and sedatives, were down 9.6% at 1,667.5 pence by 0739 GMT and were the biggest loser on the UK blue-chip index.

Hikma cited the outlook change to U.S.-based Jazz Pharmaceuticals on Wednesday saying it expects launch of authorized copycats of Xyrem, a treatment for narcolepsy, to happen in late 2022, or possibly even in January 2023.

Under a 2017 agreement with Jazz, Hikma had a set launch date of Jan. 1, 2023 for its generic version of Xyrem, or possibly earlier, depending on market conditions. Hikma was hoping for a launch in mid-2022.

Peel Hunt analysts in a note said although the forecast cut "is obviously disappointing, it is merely phasing (of revenue)".

https://www.marketscreener.com/quote/stock/HIKMA-PHARMACEUTICALS-PLC-9590215/news/Drugmaker-Hikma-drops-on-slashing-generics-unit-forecasts-40277454/

argenx: Positive Phase 3 data from thrombocytopenia trial

 Study met primary endpoint, demonstrating a higher proportion of sustained platelet response with VYVGART treatment compared to placebo (p=0.0316); responders observed across patient types regardless of prior therapy or disease severity

Statistically significant separation from placebo in key platelet-derived secondary endpoints

Safety and tolerability profile of VYVGART is consistent with previous clinical trials; ADVANCE is first registrational trial with chronic dosing out to 24 weeks

Topline data expected in first quarter 2023 from ADVANCE-SC, the second pivotal trial required for registration in primary immune thrombocytopenia (ITP)

https://finance.yahoo.com/news/argenx-announces-positive-phase-3-050000275.html

Intercept to Sell Ocaliva in PBC in Markets Outside U.S. for up to $450M

 Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept

Additionally, Intercept will receive royalties on any future ex-U.S. net sales of obeticholic acid in NASH

Intercept to discuss further details during Q1 2022 earnings call on Friday, May 6th at 8:30 a.m. ET

The conference call on Friday, May 6, will be available on the investor page of Intercept’s website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free) with passcode 7738727. Archived webcasts will be available on Intercept’s website for approximately two weeks.

https://finance.yahoo.com/news/intercept-announces-advanz-pharma-acquire-111700177.html

RBC Capital Sees 'Multiple High-Risk' On This Neurology-Focused Stock

 

• RBC Capital Markets writes that Prothena Corporation plc (NASDAQ: PRTA) believes that the recent stock downside provides an entry point and that progress with the programs and improved sentiment in the space could drive appreciation.

• Over the past month, the stock has lost 27%, and over the last six months, the stock price has dropped almost 50%.

• RBC lowered the price target from to following coverage transfer, maintaining Outperform, Speculative Risk rating.

• RBC sees a high risk but a considerable potential opportunity for birtamimab if successful in AL amyloidosis.

• Birtamimab is an amyloid-clearing monoclonal antibody recently moved into phase 3 for Stage IV AL amyloidosis patients. A post-hoc analysis of the prior study showed a strong survival advantage in advanced pts.

• "While data are not expected before 2024, given that it is PRTA's most advanced wholly-owned candidate, we believe it will remain an important potential value contributor," RBC writes.

https://finance.yahoo.com/news/why-rbc-capital-sees-multiple-194404978.html

Transcript: Sarepta Therapeutics earnings call

 https://www.marketscreener.com/quote/stock/SAREPTA-THERAPEUTICS-INC-11204214/news/Transcript-Sarepta-Therapeutics-Inc-Q1-2022-Earnings-Call-May-04-2022-40274594/

Transcript: Ligand Pharma earnings call

 https://www.marketscreener.com/quote/stock/LIGAND-PHARMACEUTICALS-IN-17306/news/Transcript-Ligand-Pharmaceuticals-Incorporated-Q1-2022-Earnings-Call-May-04-2022-40274703/