Mayne Pharma Group received a complete response letter (CRL) from the US FDA regarding the application for a generic version of NuvaRing. Management is confident the issues raised by the FDA will be addressed in a timely matter.
Read MoreScript volume trends indicate competitors continue to take share in several of Mayne Pharma’s categories, the broker notes, albeit at a slower pace than in FY19.
Read MoreMayne Pharma has entered into a supply agreement with Chinese base manufacturer Novast Laboratories for 13 US generic oral contraceptive products, including five not previously marketed.
Read MoreMayne Pharma has entered into a supply agreement with Chinese base manufacturer Novast Laboratories for 13 US generic oral contraceptive products, including five not previously marketed.
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Generic drugmaker, Mayne Pharma shares went for a little run yesterday after the company revealed a link up with a fellow generic maker from China to try and make deeper inroads into the US contraceptive market.
Read MoreReported operating earnings (EBITDA) were below Macquarie’s estimates. Generics revenue fell by -33% with underlying gross margins down -11%. Meanwhile, growth in specialty brands moderated.
Read MoreMayne Pharma has completed its response to the US FDA regarding its generic NuvaRing application, although any approval is not anticipated before the second half of 2020.
Read MoreMayne Pharma aspires to have more than 60% of its FY24 revenue from US specialty products, although significant challenges in generics are likely to beset the business in the interim.
Read MoreThe company has indicated that gross revenue for the first four months of FY20 is down -16%. Key products in generics, liothyronine, and dofetilide, continue to lose share to competitors. Specialty revenue was broadly flat. Contract services revenue increased by 16%.
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Bad news Friday, at least for three ASX-listed companies. 7-Eleven’s decision to walk away on a supply deal has left Metcash shares deep in the red while Gentrack and Mayne Pharma have disappointed investors with new profit warnings.
Read MoreThe launch of new generic drugs fentora and efudex has been strong, with 40% and 30% market share respectively. Yet Credit Suisse suspects this has not been enough to offset competition and earnings decline in the first half.
Read MoreThe company has signed an exclusive licence and supply agreement to commercialise a combined oral contraceptive in the US for total consideration of US$295m. The product is to be launched in the second half of FY21, subject to FDA approval.
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Mayne Pharma shares jumped nearly 19% yesterday a near five-month high after the company revealed an exclusive long-term deal to sell a new contraceptive drug in the USA.
Read MoreA big loss for generics pharmaceuticals maker Mayne Pharma in 2018-19 surprisingly produced a big gain, meanwhile listed horticulture producer and distributor Costa Group has reported a 15% drop in statutory interim profit.
Read MoreCredit Suisse reviews script volume trends for the company’s key generic and specialty brands. With limited improvement in the final six weeks of FY19 the broker envisages downside risk to consensus forecasts.
Read MoreThe company has announced a significant deterioration in the performance of its generic products since the first half results because of increased competition and US$4m in one-off adverse items. The high-margin specialty brands revenue is also weaker than expected.
Read MoreA rather severe confession time yesterday from generic drug group, Mayne Pharma with a warning of a big slide in revenue and profit and a possible write-down of asset values.
Read MoreMayne Pharma’s result was a big improvement on a weak previous period but was currency-assisted and disappointed nonetheless. Specialty brands stood out in revenue terms, the broker notes, but costs were elevated for various reasons.
Read MoreGeneric drugs group, Mayne Pharma saw its shares dip yesterday in the wake of yet another poor trading update.
Read MoreGeneric drug group, Mayne Pharma disappointed investors yesterday with the release of preliminary results for 2016-17 underwhelming investors.and sending the shares down nearly 10% to 81 cents.
Read MoreMayne Pharma Group’s (MYX) share price fell more than 10% to $1.20 yesterday and for that you can partly blame President Donald Trump and his erratic talk about controlling drug prices.
Read MoreDrug maker Mayne Pharma (MYX) is one of those rare stocks where investors expect much more from it in the coming year, than they saw in the year to June 30.
Read MoreMayne Pharma shares surged 28% yesterday after the company confirmed it had raised over half a billion in an institutional placement at $1.50 a share and rights issue as part of its dramatic move into the competitive US generic drugs market.
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